FDA product code GCI: Laryngoscope, Endoscope
GCI is the FDA product code for laryngoscope, endoscope. It is a Class II device, regulated under 21 CFR 876.1500 and reviewed by the General and Plastic Surgery panel. FDA has cleared 14 510(k) submissions under GCI, from 12 different applicants. The average 510(k) review took 113 days (median 86). FDA has posted 5 recalls for GCI devices.
Classification
| Field | Value |
|---|---|
| Device name | Laryngoscope, Endoscope |
| Device class | Class II |
| Regulation | 21 CFR 876.1500 |
| Review panel | SU — General and Plastic Surgery |
| Medical specialty | Gastroenterology, Urology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Compare with all 510(k) review times · Search every GCI clearance
Top GCI applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Birtcher Medical Systems, Inc. | 2 | 1993-10-27 |
| Conmedcorp | 2 | 1992-04-15 |
| Surgicon, Inc. | 1 | 2002-08-15 |
| Computer Motion, Inc. | 1 | 2000-11-03 |
| Karl Storz Imaging, Inc. | 1 | 2000-07-17 |
7 more applicants have GCI clearances. See the full list in Caduvo.
Most recent GCI clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K021747 | Surgicon, Inc. | DEGALL LAPAROSCOPIC GALLBLADDER EXTRACTOR | 2002-08-15 | 79 |
| K003222 | Computer Motion, Inc. | MODIFICATION TO HERMES OPERATING ROOM CONTROL CENTER | 2000-11-03 | 18 |
| K001362 | Karl Storz Imaging, Inc. | KARL STORZ 3D VIDEO SYSTEM | 2000-07-17 | 80 |
| K933515 | T-Med, Inc. | BOOTY ENDOSCOPE WARMER | 1993-10-27 | 99 |
| K930302 | Birtcher Medical Systems, Inc. | BIRTCHER SURE CLEAN INSTRUMENT SYSTEM | 1993-10-27 | 279 |
Recalls for GCI devices
5 product recalls in 2 recall events; 0 initiated in the last five years and 4 still open. Most recent: 2020-05-12.
| Year | Recalls |
|---|---|
| 2020 | 4 |
Frequently asked questions
What is FDA product code GCI?
GCI is the FDA product code for laryngoscope, endoscope. It is a Class II device, regulated under 21 CFR 876.1500 and reviewed by the General and Plastic Surgery panel.
What device class is GCI?
Class II, regulation 21 CFR 876.1500. Typical premarket route: 510(k).
How long does a 510(k) take for product code GCI?
Across 14 cleared submissions the average was 113 days from receipt to decision (median 86).
Which companies have the most GCI clearances?
Birtcher Medical Systems, Inc. (2); Conmedcorp (2); Surgicon, Inc. (1); Computer Motion, Inc. (1); Karl Storz Imaging, Inc. (1).
Have GCI devices been recalled?
Yes: 5 product recalls across 2 recall events; the most recent began 2020-05-12.
Next steps
- Run an FDA pathway report with predicate devices for product code GCI
- Run a recall and safety report across every GCI manufacturer
- Watch product code GCI 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.
All General and Plastic Surgery product codes · FDA product code lookup · 510(k) database search · 510(k) review times