Hobbs Medical, Inc.
Stafford Springs, CT, US
HOBBS MEDICAL, INC. appears in FDA device records in Stafford Springs, CT. FDA records list 21 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show 74 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 21 510(k) clearances for Hobbs Medical, Inc. between 1983 and 2024. The busiest year on record is 1984, with 5. The most recent is 2024, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1983 | 2 |
| 1984 | 5 |
| 1985 | 2 |
| 1986 | 2 |
| 1987 | 1 |
| 1989 | 1 |
| 1991 | 1 |
| 1992 | 2 |
| 1993 | 1 |
| 2003 | 1 |
| 2010 | 1 |
| 2020 | 1 |
| 2024 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K241874 | Aspiration Catheter (2189) | OCX | Substantially Equivalent | |
| K182927 | Pulmonary Cytology Brush | BTG | Substantially Equivalent | |
| K093079 | TOUCHSOFT COAGULATOR WITH BANANA FITTING, MODEL 4581 AND WITH UNIVERSAL FITTING, MODEL 4581-U | KNS | Substantially Equivalent | |
| K030765 | HOBBS MISTIFIER SPRAY CATHETER | OCX | Substantially Equivalent | |
| K933354 | HOBBS MEDICAL CLEANING BRUSH | FEB | Substantially Equivalent | |
| K922396 | FUJINON FORCEPS -- MODIFICATION | FCL | Substantially Equivalent | |
| K921026 | PRESSURE GAUGE | KNT | Substantially Equivalent | |
| K914358 | ENCAPSULATED GUIDEWIRE WITH FLEXIBLE TIP | EYB | Substantially Equivalent | |
| K893729 | HOBBS MEDICAL MICROBIOLOGY BRUSH | FDX | Substantially Equivalent | |
| K872509 | LINDEN STONE EXTRACTION BALLOON | FGE | Substantially Equivalent | |
| K860593 | ET/RT PAPILLOTOME | KNS | Substantially Equivalent | |
| K860582 | TBI NEEDLE | GAA | Substantially Equivalent | |
| K844550 | HOBBS MEDICAL/JAYCO ASPIRATION CATHETER | OCX | Substantially Equivalent | |
| K844074 | HOBBS MEDICAL POLYPECTOMY SNARE | OCZ | Substantially Equivalent | |
| K834413 | DILATION BALLOON CATHETER | FGE | Substantially Equivalent | |
| K834401 | URETERAL DOUBLE PIGTAIL STENT | FAD | Substantially Equivalent | |
| K834351 | BILIARY INDWELLING STENT | FGE | Substantially Equivalent | |
| K834414 | ERCP CANNULA | ODD | Substantially Equivalent | |
| K834402 | GASTROINTESTINAL SHEATH BRUSH | FDX | Substantially Equivalent | |
| K833124 | HOBBS MEDICAL RETRIEVAL BASKET | OCZ | Substantially Equivalent | |
| K833125 | HOBBS MEDICAL GRASPING FORCEPS | OCZ | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 1220592 | 1220592 | HOBBS MEDICAL, INC. | 8 Spring St, Stafford Springs, CT 06076 US | 2026 | and 3 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- FEBAccessories, Cleaning, For Endoscope
- EOQBronchoscope (Flexible Or Rigid)
- BTGBrush, Biopsy, Bronchoscope (Non-Rigid)
- GEEBrush, Biopsy, General & Plastic Surgery
- FGYCannula, Injection
- EYBCatheter, Ureteral, Gastro-Urology
- FDXEndoscopic Cytology Brush
- OCZEndoscopic Grasping/Cutting Instrument, Non-Powered
- FBKEndoscopic Injection Needle, Gastroenterology-Urology
- OCXEndoscopic Irrigation/Suction System
- ODDEndoscopic Retrograde Cholangiopancreatography (Ercp) Cannula
- LDZFixative, Alcohol Containing
- FCLForceps, Biopsy, Non-Electric
- GAANeedle, Aspiration And Injection, Disposable
- FADStent, Ureteral
- FGEStents, Drains And Dilators For The Biliary Ducts
- KNTTubes, Gastrointestinal (And Accessories)
- KNSUnit, Electrosurgical, Endoscopic (With Or Without Accessories)
Recall records
Showing 25 of 74| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-0476-2025 | Posi-Stop Injection Needle, 25 Gauge, Catalog Number: 4723 | Injection solutions would not flow as intended through the tip of 25ga-sized needles. Investigations that some units contained debris from the manufacturing process within the inner sheath that blocked the ID of the needle. | Class II | Open, Classified | |
| Z-0475-2025 | Posi-Stop Injection Needle, 25 Gauge, Catalog Number: 4722 | Injection solutions would not flow as intended through the tip of 25ga-sized needles. Investigations that some units contained debris from the manufacturing process within the inner sheath that blocked the ID of the needle. | Class II | Open, Classified | |
| Z-0474-2025 | Posi-Stop Injection Needle, 25 Gauge, Catalog Number: 4718 | Injection solutions would not flow as intended through the tip of 25ga-sized needles. Investigations that some units contained debris from the manufacturing process within the inner sheath that blocked the ID of the needle. | Class II | Open, Classified | |
| Z-0473-2025 | Posi-Stop Injection Needle, 25 Gauge, Catalog Number: 4704 | Injection solutions would not flow as intended through the tip of 25ga-sized needles. Investigations that some units contained debris from the manufacturing process within the inner sheath that blocked the ID of the needle. | Class II | Open, Classified | |
| Z-0472-2025 | Posi-Stop Injection Needle, 23 Gauge, Catalog Number: 4721 | Injection solutions would not flow as intended through the tip of 25ga-sized needles. Investigations that some units contained debris from the manufacturing process within the inner sheath that blocked the ID of the needle. | Class II | Open, Classified | |
| Z-0471-2025 | Posi-Stop Injection Needle, 23 Gauge, Catalog Number: 4716 | Injection solutions would not flow as intended through the tip of 25ga-sized needles. Investigations that some units contained debris from the manufacturing process within the inner sheath that blocked the ID of the needle. | Class II | Open, Classified | |
| Z-0470-2025 | Posi-Stop Injection Needle, 23 Gauge, Catalog Number: 4706 | Injection solutions would not flow as intended through the tip of 25ga-sized needles. Investigations that some units contained debris from the manufacturing process within the inner sheath that blocked the ID of the needle. | Class II | Open, Classified | |
| Z-0469-2025 | Posi-Stop Injection Needle, 23 Gauge, Catalog Number: 4702 | Injection solutions would not flow as intended through the tip of 25ga-sized needles. Investigations that some units contained debris from the manufacturing process within the inner sheath that blocked the ID of the needle. | Class II | Open, Classified | |
| Z-0468-2025 | Posi-Stop Injection Needle, 23 Gauge, Catalog Number: 4720 | Injection solutions would not flow as intended through the tip of 25ga-sized needles. Investigations that some units contained debris from the manufacturing process within the inner sheath that blocked the ID of the needle. | Class II | Open, Classified | |
| Z-0070-2023 | Hobbs Medical Polypectomy Snare Catalog Number: 4575-OLY | Device label display an incorrect expiration date, extends the shelf life of the product. Affected product distributed in the United States from 3/25/2018 to 9/28/2020, expiration dates between 2022-11-01 and 2025-09-01 (Devices have a lot number ending in R, or are kits containing at least 1 device with a lot number ending in R.) | Class II | Open, Classified | |
| Z-0069-2023 | Hobbs Medical Polypectomy Snare Catalog Number: 4565-OLY | Device label display an incorrect expiration date, extends the shelf life of the product. Affected product distributed in the United States from 3/25/2018 to 9/28/2020, expiration dates between 2022-11-01 and 2025-09-01 (Devices have a lot number ending in R, or are kits containing at least 1 device with a lot number ending in R.) | Class II | Open, Classified | |
| Z-0068-2023 | Hobbs Medical Polypectomy Snare Catalog Number: 4563-OLY | Device label display an incorrect expiration date, extends the shelf life of the product. Affected product distributed in the United States from 3/25/2018 to 9/28/2020, expiration dates between 2022-11-01 and 2025-09-01 (Devices have a lot number ending in R, or are kits containing at least 1 device with a lot number ending in R.) | Class II | Open, Classified | |
| Z-0067-2023 | Hobbs Medical Polypectomy Snare Catalog Number: 7202 | Device label display an incorrect expiration date, extends the shelf life of the product. Affected product distributed in the United States from 3/25/2018 to 9/28/2020, expiration dates between 2022-11-01 and 2025-09-01 (Devices have a lot number ending in R, or are kits containing at least 1 device with a lot number ending in R.) | Class II | Open, Classified | |
| Z-0066-2023 | Freeman Pancreatic Flexi-Stent (contained in kit 6501) Catalog Number: 6541 | Device label display an incorrect expiration date, extends the shelf life of the product. Affected product distributed in the United States from 3/25/2018 to 9/28/2020, expiration dates between 2022-11-01 and 2025-09-01 (Devices have a lot number ending in R, or are kits containing at least 1 device with a lot number ending in R.) | Class II | Open, Classified | |
| Z-0065-2023 | Freeman Pancreatic Flexi-Stent Catalog Number: 6584 | Device label display an incorrect expiration date, extends the shelf life of the product. Affected product distributed in the United States from 3/25/2018 to 9/28/2020, expiration dates between 2022-11-01 and 2025-09-01 (Devices have a lot number ending in R, or are kits containing at least 1 device with a lot number ending in R.) | Class II | Open, Classified | |
| Z-0064-2023 | Freeman Pancreatic Flexi-Stent Catalog Number: 6582 | Device label display an incorrect expiration date, extends the shelf life of the product. Affected product distributed in the United States from 3/25/2018 to 9/28/2020, expiration dates between 2022-11-01 and 2025-09-01 (Devices have a lot number ending in R, or are kits containing at least 1 device with a lot number ending in R.) | Class II | Open, Classified | |
| Z-0063-2023 | Freeman Pancreatic Flexi-Stent Catalog Number: 6568 | Device label display an incorrect expiration date, extends the shelf life of the product. Affected product distributed in the United States from 3/25/2018 to 9/28/2020, expiration dates between 2022-11-01 and 2025-09-01 (Devices have a lot number ending in R, or are kits containing at least 1 device with a lot number ending in R.) | Class II | Open, Classified | |
| Z-0062-2023 | Freeman Pancreatic Flexi-Stent Catalog Number: 6567 | Device label display an incorrect expiration date, extends the shelf life of the product. Affected product distributed in the United States from 3/25/2018 to 9/28/2020, expiration dates between 2022-11-01 and 2025-09-01 (Devices have a lot number ending in R, or are kits containing at least 1 device with a lot number ending in R.) | Class II | Open, Classified | |
| Z-0061-2023 | Freeman Pancreatic Flexi-Stent Catalog Number: 6566 | Device label display an incorrect expiration date, extends the shelf life of the product. Affected product distributed in the United States from 3/25/2018 to 9/28/2020, expiration dates between 2022-11-01 and 2025-09-01 (Devices have a lot number ending in R, or are kits containing at least 1 device with a lot number ending in R.) | Class II | Open, Classified | |
| Z-0060-2023 | Freeman Pancreatic Flexi-Stent Catalog Number: 6562 | Device label display an incorrect expiration date, extends the shelf life of the product. Affected product distributed in the United States from 3/25/2018 to 9/28/2020, expiration dates between 2022-11-01 and 2025-09-01 (Devices have a lot number ending in R, or are kits containing at least 1 device with a lot number ending in R.) | Class II | Open, Classified | |
| Z-0059-2023 | Freeman Pancreatic Flexi-Stent Catalog Number: 6548 | Device label display an incorrect expiration date, extends the shelf life of the product. Affected product distributed in the United States from 3/25/2018 to 9/28/2020, expiration dates between 2022-11-01 and 2025-09-01 (Devices have a lot number ending in R, or are kits containing at least 1 device with a lot number ending in R.) | Class II | Open, Classified | |
| Z-0058-2023 | Freeman Pancreatic Flexi-Stent Catalog Number: 6544 | Device label display an incorrect expiration date, extends the shelf life of the product. Affected product distributed in the United States from 3/25/2018 to 9/28/2020, expiration dates between 2022-11-01 and 2025-09-01 (Devices have a lot number ending in R, or are kits containing at least 1 device with a lot number ending in R.) | Class II | Open, Classified | |
| Z-0057-2023 | Freeman Pancreatic Flexi-Stent Catalog Number: 6535 | Device label display an incorrect expiration date, extends the shelf life of the product. Affected product distributed in the United States from 3/25/2018 to 9/28/2020, expiration dates between 2022-11-01 and 2025-09-01 (Devices have a lot number ending in R, or are kits containing at least 1 device with a lot number ending in R.) | Class II | Open, Classified | |
| Z-0056-2023 | Freeman Pancreatic Flexi-Stent Catalog Number: 6534 | Device label display an incorrect expiration date, extends the shelf life of the product. Affected product distributed in the United States from 3/25/2018 to 9/28/2020, expiration dates between 2022-11-01 and 2025-09-01 (Devices have a lot number ending in R, or are kits containing at least 1 device with a lot number ending in R.) | Class II | Open, Classified | |
| Z-0055-2023 | Freeman Pancreatic Flexi-Stent Catalog Number: 6533 | Device label display an incorrect expiration date, extends the shelf life of the product. Affected product distributed in the United States from 3/25/2018 to 9/28/2020, expiration dates between 2022-11-01 and 2025-09-01 (Devices have a lot number ending in R, or are kits containing at least 1 device with a lot number ending in R.) | Class II | Open, Classified |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain