Company ยท US
Gm Engineering, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1993 to 1995. Name variants (Inc, Corp, punctuation) are merged.
11510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| EQH | Source, Carrier, Fiberoptic Light | 2 |
| FDC | Resectoscope, Working Element | 2 |
| GCJ | Laparoscope, General & Plastic Surgery | 2 |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | 1 |
| GEX | Powered Laser Surgical Instrument | 1 |
| KAR | Irrigator, Sinus | 1 |
| KYH | Endoscope, Ophthalmic | 1 |
| LKF | Cannula, Manipulator/Injector, Uterine | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Sep 12, 1995 | K953348 | ARTICULATING RETRACTOR TISSUE RETRACTORS Gm Engineering, Inc. | GCJ |
| May 30, 1995 | K942626 | CONTINUOUS FLOW BIOPSY PROBE Gm Engineering, Inc. | FDC |
| Jan 26, 1995 | K932394 | BERNSTEIN(TM) UTERINE MANIPULATOR Gm Engineering, Inc. | LKF |
| Aug 23, 1994 | K941661 | GM OPTI*CAM CAMER WITH DENTAL FIBER OPTIC LIGHT Gm Engineering, Inc. | EQH |
| Aug 19, 1994 | K942703 | GM REUSABLE AND DISPOSABLE TROCAR AND GM REUSABLE AND DISPOSABLE ULTRA-LIGHT CANNULA Gm Engineering, Inc. | GCJ |
| Jul 20, 1994 | K941662 | GM OPTI*CAM CAMERA WITH ENT FIBER OPTIC LIGHT Gm Engineering, Inc. | EQH |
| May 24, 1994 | K941660 | GM OPTI*CAM CAMERA WITH FIBER OPTIC LIGHT Gm Engineering, Inc. | KYH |
| Feb 25, 1994 | K933962 | GM CONTINUOUS FLOW BIOPSY PROBE Gm Engineering, Inc. | FDC |
| Dec 1, 1993 | K934035 | GM MONOPOLAR/FRAZIER SUCTION PROBE Gm Engineering, Inc. | GEI |
| Dec 1, 1993 | K930611 | TRUE FLOW(TM) VALVE Gm Engineering, Inc. | GEX |
| Aug 30, 1993 | K931398 | GM SWIVEL VIDEO (TM) IRRIGATOR Gm Engineering, Inc. | KAR |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||