FDA product code GCP: Endoscope, Ac-Powered And Accessories
GCP is the FDA product code for endoscope, ac-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 13 510(k) submissions under GCP, from 11 different applicants. The average 510(k) review took 66 days (median 61). FDA has posted 5 recalls for GCP devices, 3 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Endoscope, Ac-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 GCP clearance
Top GCP applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Propper Mfg. Co., Inc. | 3 | 1977-10-20 |
| North Eos Industries, Inc. | 1 | 1996-04-10 |
| Porges Corp. | 1 | 1990-01-30 |
| Medical Dynamics, Inc. | 1 | 1989-12-27 |
| Endovations | 1 | 1986-09-22 |
6 more applicants have GCP clearances. See the full list in Caduvo.
Most recent GCP clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K954614 | North Eos Industries, Inc. | EOS BRAND DISPOSABLE PROCTOSCOPE | 1996-04-10 | 188 |
| K896505 | Porges Corp. | PORGES UNIVERSAL HANDLES | 1990-01-30 | 76 |
| K896008 | Medical Dynamics, Inc. | MODEL 6500 MERCURY ARC LIGHT SOURCE | 1989-12-27 | 75 |
| K862424 | Endovations | STEERABLE CATHETER SYSTEM | 1986-09-22 | 88 |
| K860103 | Endotherapeutics | MOD. ENDOPORT SINGLE-USE TROCAR AND SLEEVE | 1986-02-12 | 33 |
Recalls for GCP devices
5 product recalls in 5 recall events; 3 initiated in the last five years and 3 still open. Most recent: 2025-11-11.
| Year | Recalls |
|---|---|
| 2017 | 2 |
| 2024 | 2 |
| 2025 | 1 |
Frequently asked questions
What is FDA product code GCP?
GCP is the FDA product code for endoscope, ac-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 GCP?
Class II, regulation 21 CFR 876.1500. Typical premarket route: 510(k).
How long does a 510(k) take for product code GCP?
Across 13 cleared submissions the average was 66 days from receipt to decision (median 61).
Which companies have the most GCP clearances?
Propper Mfg. Co., Inc. (3); North Eos Industries, Inc. (1); Porges Corp. (1); Medical Dynamics, Inc. (1); Endovations (1).
Have GCP devices been recalled?
Yes: 5 product recalls across 5 recall events; the most recent began 2025-11-11.
Next steps
- Run an FDA pathway report with predicate devices for product code GCP
- Run a recall and safety report across every GCP manufacturer
- Watch product code GCP 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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