FDA product code GCS: Endoscope, Battery-Powered And Accessories
GCS is the FDA product code for endoscope, battery-powered and accessories. It is a Class II device, regulated under 21 CFR 876.1500 and reviewed by the Gastroenterology and Urology panel. FDA has cleared 9 510(k) submissions under GCS, from 8 different applicants. The average 510(k) review took 144 days (median 135).
Classification
| Field | Value |
|---|---|
| Device name | Endoscope, Battery-Powered And Accessories |
| Device class | Class II |
| Regulation | 21 CFR 876.1500 |
| Review panel | GU — Gastroenterology and Urology |
| Medical specialty | Gastroenterology, Urology |
| Premarket route | 510(k) |
Compare with all 510(k) review times · Search every GCS clearance
Top GCS applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Inman Medical Corp. | 2 | 1993-08-31 |
| Instrument Makar, Inc. | 1 | 1995-02-23 |
| Ideal Medical, Inc. | 1 | 1994-12-08 |
| Aesculap, Inc. | 1 | 1993-09-13 |
| Leisegang Medical, Inc. | 1 | 1993-07-02 |
3 more applicants have GCS clearances. See the full list in Caduvo.
Most recent GCS clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K944062 | Instrument Makar, Inc. | LAPRASCOPIC GRASPER | 1995-02-23 | 188 |
| K944067 | Ideal Medical, Inc. | PEANUT WAND, MODIFICATION | 1994-12-08 | 135 |
| K933201 | Aesculap, Inc. | AESCULAP TROCAR INSTRUMENT SET | 1993-09-13 | 74 |
| K932762 | Inman Medical Corp. | 10.0MM SUCTION/IRRIGATION PROBE & TUBING KIT | 1993-08-31 | 84 |
| K933371 | Inman Medical Corp. | IMC ENDOSCOPIC INSTRUMENT HOLDER | 1993-08-06 | 28 |
Recalls for GCS devices
openFDA lists no recalls for product code GCS.
Frequently asked questions
What is FDA product code GCS?
GCS is the FDA product code for endoscope, battery-powered and accessories. It is a Class II device, regulated under 21 CFR 876.1500 and reviewed by the Gastroenterology and Urology panel.
What device class is GCS?
Class II, regulation 21 CFR 876.1500. Typical premarket route: 510(k).
How long does a 510(k) take for product code GCS?
Across 9 cleared submissions the average was 144 days from receipt to decision (median 135).
Which companies have the most GCS clearances?
Inman Medical Corp. (2); Instrument Makar, Inc. (1); Ideal Medical, Inc. (1); Aesculap, Inc. (1); Leisegang Medical, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code GCS
- Run a recall and safety report across every GCS manufacturer
- Watch product code GCS for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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