GCS
9 FDA 510(k) clearances · Product code
135 daysmedian time to decision
318 days90th percentile
9clearances measured
FDA profile
- Official device name
- Endoscope, Battery-Powered And Accessories
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.1500
- Medical specialty
- Gastroenterology, Urology
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| LAPRASCOPIC GRASPER (K944062) | Instrument Makar, Inc. | 1995-02-23 |
| PEANUT WAND, MODIFICATION (K944067) | Ideal Medical, Inc. | 1994-12-08 |
| AESCULAP TROCAR INSTRUMENT SET (K933201) | Aesculap, Inc. | 1993-09-13 |
| 10.0MM SUCTION/IRRIGATION PROBE & TUBING KIT (K932762) | Inman Medical Corp. | 1993-08-31 |
| IMC ENDOSCOPIC INSTRUMENT HOLDER (K933371) | Inman Medical Corp. | 1993-08-06 |
| LEISEGANG LAPAROSCOPIC IRRIGATION SYSTEM/ACCESS (K924134) | Leisegang Medical, Inc. | 1993-07-02 |
| GRASP FORCEPS/SCISSORS/NEEDLE HOLDER/DISSECTOR (K931340) | Baxter Healthcare Corp | 1993-07-01 |
| M.I.S. TROCAR-CANNULA (K925276) | M.I.S. Technology, Inc. | 1993-05-24 |
| LAPAROSCOPIC RETRACTOR SYSTEM (K921006) | Laparomed Corp. | 1992-07-28 |
Track GCS automatically
Every clearance here is in the API, with alerts when new ones post.