Sage Products LLC
Cary, IL, US
SAGE PRODUCTS LLC appears in FDA device records in Cary, IL. FDA records list 31 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show 2 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 31 510(k) clearances for Sage Products LLC between 1978 and 1998. The busiest year on record is 1997, with 5. The most recent is 1998, with 2.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1978 | 1 |
| 1979 | 1 |
| 1980 | 4 |
| 1982 | 4 |
| 1983 | 1 |
| 1987 | 2 |
| 1989 | 1 |
| 1990 | 1 |
| 1994 | 2 |
| 1995 | 3 |
| 1996 | 4 |
| 1997 | 5 |
| 1998 | 2 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K972705 | RESHEATHER DEVICE-METAL OR PLASTIC, RESHEATER/ NEEDLE HOLDER DEVICE-PLASTIC | FMI | Substantially Equivalent | |
| K980490 | SAGE PRODUCTS INC, SHARPS DISPOSAL CONTAINERS WITH SCREW TOP CAPS | MMK | Substantially Equivalent | |
| K973911 | 2 GALLON ALTERNATE CARE SHARPS CONTAINER | FMI | Substantially Equivalent | |
| K972279 | SHARPS SHUTTLE | FMI | Substantially Equivalent | |
| K970135 | NITRILE GLOVES | LZC | Substantially Equivalent | |
| K972302 | POCKET COUNT OR SAFETCOUNT | LWH | Substantially Equivalent | |
| K964168 | PROCEDURE SPECIFIC KITS | FXX | Substantially Equivalent | |
| K963986 | STP SYSTEM PVA WITH ZINC | LIO | Substantially Equivalent | |
| K964026 | STP SYSTEM - SAF | LIO | Substantially Equivalent | |
| K964027 | STP SYSTEM-PVA WITH MERCURY | LIO | Substantially Equivalent | |
| K962168 | MUCUS SPECIMEN TRAP | KDQ | Substantially Equivalent | |
| K943660 | PHLEBOTOMY SHARPS DISPOSAL CONTAINERS | MMK | Substantially Equivalent | |
| K943659 | ANCILLARY AND LARGE VOLUME SHARPS DISPOSAL CONTAINERS | MMK | Substantially Equivalent | |
| K943658 | CHEMOTHERAPY WASTE DISPOSAL CONTAINERS | MMK | Substantially Equivalent | |
| K941991 | IN-ROOM AND SHARPSTAR | MMK | Substantially Equivalent | |
| K933370 | STOOL TRANSPORT/PROCESSOR | LKS | Substantially Equivalent | |
| K901806 | SUCTION ORA-SWAB(R) BRUSH KIT | EIA | Unknown | |
| K894064 | STERILE HAND COVER | LYU | Substantially Equivalent | |
| K874888 | ISOLATION GOWN | FYC | Substantially Equivalent | |
| K873569 | BLOOD NEEDLE HOLDER | FMI | Substantially Equivalent | |
| K823413 | MOUTH CARE KIT W/TOOTHBRUSH | Substantially Equivalent | ||
| K823411 | PEDIATRIC URINE COLLECTOR | KNX | Substantially Equivalent | |
| K823412 | ARM BOARD W/I.V COVERING | BTX | Substantially Equivalent | |
| K820246 | PREFILLED SPECIMEN CONTAINER | KDT | Substantially Equivalent | |
| K813408 | SAGE 2200 STERILE SPECIMEN CONTAINER | FMT | Substantially Equivalent | |
| K800946 | URINARY CATHETER SAMPLING KIT | KDT | Substantially Equivalent | |
| K800947 | MIDSTREAM COLLECTION KIT | FMH | Substantially Equivalent | |
| K800397 | ELLIK BLADDER EVACUATOR | KQT | Substantially Equivalent | |
| K800309 | SPECIMEN COLLECTION PAN | FMH | Substantially Equivalent | |
| K790291 | OPERATING ROOM SPECIMEN CONTAINER | FMH | Substantially Equivalent | |
| K781557 | 24-HOUR URINE COLLECTION COOLING WRAP | FMH | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 1419181 | 1419181 | SAGE PRODUCTS LLC | 3909 3 Oaks Rd, CARY, IL 60013 US | 2026 | and 4 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- LYUAccessory, Surgical Apparel
- KXFApplicator, Absorbent Tipped, Non-Sterile
- KMEBedding, Disposable, Medical
- BTXBoard, Arm (With Cover), Sterile
- KDQBottle, Collection, Vacuum
- JOLCatheter And Tip, Suction
- KNXCollector, Urine, (And Accessories) For Indwelling Catheter
- NZUCollector, Urine, Powered, Non Indwelling Catheter
- MMKContainer, Sharps
- KDTContainer, Specimen Mailer And Storage, Sterile
- FMHContainer, Specimen, Sterile
- LWHCounter, Sponge, Surgical
- MACDecontamination Kit
- LKSDevice, Parasite Concentration
- LIODevice, Specimen Collection
- FMRDevice, Transfer, Patient, Manual
- KQTEvacuator, Gastro-Urology
- FRLFiber, Medical, Absorbent
- FYCGown, Isolation, Surgical
- FSALift, Patient, Non-Ac-Powered
- FXXMask, Surgical
- IKYMattress, Flotation Therapy, Non-Powered
- LZCMedical Glove, Specialty
- FMINeedle, Hypodermic, Single Lumen
- NSBPatient Personal Hygiene Kit
- BRWProtector, Dental
- FMPProtector, Skin Pressure
- CCXSupport, Patient Position
- EFWToothbrush, Manual
- EIAUnit, Operative Dental
- FMTWarmer, Infant Radiant
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-0356-2024 | stryker Sage PrimaFit External Urine Management System for the Female Anatomy | A small percentage of devices in three lots of product may contain a tape with a natural rubber latex adhesive which is not declared on the label | Class II | Open, Classified | |
| Z-2139-2019 | Toothete Oral Care Sodium Bicarbonate Mouthpaste, Net Wt. 1/3 oz/ 9g, included in Independent Care System. The system is an oral care convenience kit which includes: an Ultra-Soft Toothbrush, 0.5 oz. tube of Mouth Moisturizer, 0.33 oz. /9g tube of Sodium Bicarbonate Mouthpaste and 1.5fl.oz. bottle of Corinz oral rinse. Product Usage: The mouthpaste is used to clean teeth, gums, and the tongue. | A voluntary recall of a lot (67924) of Independent Care System due to the potential for damaged Sodium Bicarbonate Mouthpaste (cosmetic) tubes. | Class II | Terminated |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain