FDA product code GCL: Esophagoscope, General & Plastic Surgery
GCL is the FDA product code for esophagoscope, general & plastic surgery. It is a Class II device, regulated under 21 CFR 876.1500 and reviewed by the Gastroenterology and Urology panel. FDA has cleared 4 510(k) submissions under GCL, from 3 different applicants. The average 510(k) review took 121 days (median 116).
Definition
If the device is reusable, validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission (82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).
Classification
| Field | Value |
|---|---|
| Device name | Esophagoscope, General & Plastic Surgery |
| 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 GCL clearance
Top GCL applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Pentax Precision Instrument Corp. | 2 | 1995-05-30 |
| Phx Technologies Corp. | 1 | 1994-02-17 |
| C.R. Bard, Inc. | 1 | 1992-10-30 |
Most recent GCL clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K951198 | Pentax Precision Instrument Corp. | FE-34TH, FIBER ESOPHAGOSCOPE | 1995-05-30 | 75 |
| K951197 | Pentax Precision Instrument Corp. | FE-24X, FIBER ESOPHAGOSCOPE | 1995-05-30 | 75 |
| K934510 | Phx Technologies Corp. | 5,6,7,9,10,11,12MM BLUNT-TIP TROCAR OBTUR/THREAD | 1994-02-17 | 156 |
| K922086 | C.R. Bard, Inc. | BARD BIOPSY FORCEPS | 1992-10-30 | 179 |
Recalls for GCL devices
openFDA lists no recalls for product code GCL.
Frequently asked questions
What is FDA product code GCL?
GCL is the FDA product code for esophagoscope, general & plastic surgery. It is a Class II device, regulated under 21 CFR 876.1500 and reviewed by the Gastroenterology and Urology panel.
What device class is GCL?
Class II, regulation 21 CFR 876.1500. Typical premarket route: 510(k).
How long does a 510(k) take for product code GCL?
Across 4 cleared submissions the average was 121 days from receipt to decision (median 116).
Which companies have the most GCL clearances?
Pentax Precision Instrument Corp. (2); Phx Technologies Corp. (1); C.R. Bard, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code GCL
- Run a recall and safety report across every GCL manufacturer
- Watch product code GCL 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 Gastroenterology and Urology product codes · FDA product code lookup · 510(k) database search · 510(k) review times