Primrose Medical, Inc.
East Walpole, MA, US
PRIMROSE MEDICAL, INC. appears in FDA device records in East Walpole, MA. FDA records list 14 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no 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 14 510(k) clearances for Primrose Medical, Inc. between 1984 and 1989. The busiest year on record is 1989, with 6. The most recent is 1989, with 6.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1984 | 2 |
| 1987 | 1 |
| 1988 | 5 |
| 1989 | 6 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K884715 | ACHELASIA BALLOON DIALATOR | KNQ | Substantially Equivalent | |
| K884714 | BILIARY DIALATOR | FGE | Substantially Equivalent | |
| K884713 | COLONIC BALLOON DIALATORS | FFP | Substantially Equivalent | |
| K884711 | URETHRAL AND URETERAL BALLOON DILATATORS | EZN | Substantially Equivalent | |
| K884712 | ESOPHAGEAL AND PYLORIC BALLOON DIALATORS | KNQ | Substantially Equivalent | |
| K884709 | ENDOSCOPES & ACCESS.(SCLEROTHERAPY/TRANSBRONCHIAL) | ODD | Substantially Equivalent | |
| K883420 | LANCET, BLOOD | FMK | Substantially Equivalent | |
| K881976 | CATHETER, INTRAVASCULAR | FOZ | Substantially Equivalent | |
| K881977 | PRESSURE INFUSOR | KZD | Substantially Equivalent | |
| K881975 | SET, INTRAVASCULAR | FPA | Substantially Equivalent | |
| K881978 | ENTERAL FEEDING TUBES | KNT | Substantially Equivalent | |
| K873493 | NINJA SCALPEL | GES | Substantially Equivalent | |
| K843071 | ESOPHAGEAL STETHOSCOPES W/ELEC CONDUCTOR | BZT | Substantially Equivalent | |
| K843070 | ESOPHAGEAL STETHOSCOPES | BZW | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 1220905 | 1220905 | PRIMROSE MEDICAL, INC. | 286 Union Street, East Walpole, MA 02032 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- GESBlade, Scalpel
- FOZCatheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
- EZNDilator, Catheter, Ureteral
- KNQDilator, Esophageal
- FFPDilator, Rectal
- ODDEndoscopic Retrograde Cholangiopancreatography (Ercp) Cannula
- KZDInfusor, Pressure, For I.V. Bags
- FMINeedle, Hypodermic, Single Lumen
- LJTPort & Catheter, Implanted, Subcutaneous, Intravascular
- FPASet, Administration, Intravascular
- FMKSingle Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature
- FGEStents, Drains And Dilators For The Biliary Ducts
- BZWStethoscope, Esophageal
- BZTStethoscope, Esophageal, With Electrical Conductors
- KNTTubes, Gastrointestinal (And Accessories)
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain