Company ยท US
Primrose Medical, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1984 to 1989. Name variants (Inc, Corp, punctuation) are merged.
14510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| KNQ | Dilator, Esophageal | 2 |
| BZT | Stethoscope, Esophageal, With Electrical Conductors | 1 |
| BZW | Stethoscope, Esophageal | 1 |
| EZN | Dilator, Catheter, Ureteral | 1 |
| FFP | Dilator, Rectal | 1 |
| FGE | Stents, Drains And Dilators For The Biliary Ducts | 1 |
| FMK | Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature | 1 |
| FOZ | Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days | 1 |
| FPA | Set, Administration, Intravascular | 1 |
| GES | Blade, Scalpel | 1 |
| KNT | Tubes, Gastrointestinal (And Accessories) | 1 |
| KZD | Infusor, Pressure, For I.V. Bags | 1 |
| ODD | Endoscopic Retrograde Cholangiopancreatography (Ercp) Cannula | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Sep 29, 1989 | K884715 | ACHELASIA BALLOON DIALATOR Primrose Medical, Inc. | KNQ |
| Sep 29, 1989 | K884714 | BILIARY DIALATOR Primrose Medical, Inc. | FGE |
| Sep 29, 1989 | K884713 | COLONIC BALLOON DIALATORS Primrose Medical, Inc. | FFP |
| Sep 29, 1989 | K884711 | URETHRAL AND URETERAL BALLOON DILATATORS Primrose Medical, Inc. | EZN |
| Sep 8, 1989 | K884712 | ESOPHAGEAL AND PYLORIC BALLOON DIALATORS Primrose Medical, Inc. | KNQ |
| Sep 8, 1989 | K884709 | ENDOSCOPES & ACCESS.(SCLEROTHERAPY/TRANSBRONCHIAL) Primrose Medical, Inc. | ODD |
| Aug 26, 1988 | K883420 | LANCET, BLOOD Primrose Medical, Inc. | FMK |
| Aug 4, 1988 | K881976 | CATHETER, INTRAVASCULAR Primrose Medical, Inc. | FOZ |
| Jul 29, 1988 | K881977 | PRESSURE INFUSOR Primrose Medical, Inc. | KZD |
| Jul 29, 1988 | K881975 | SET, INTRAVASCULAR Primrose Medical, Inc. | FPA |
| Jul 13, 1988 | K881978 | ENTERAL FEEDING TUBES Primrose Medical, Inc. | KNT |
| Sep 24, 1987 | K873493 | NINJA SCALPEL Primrose Medical, Inc. | GES |
| Aug 24, 1984 | K843071 | ESOPHAGEAL STETHOSCOPES W/ELEC CONDUCTOR Primrose Medical, Inc. | BZT |
| Aug 24, 1984 | K843070 | ESOPHAGEAL STETHOSCOPES Primrose Medical, Inc. | BZW |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||