FDA product code GCF: Proctoscope
GCF is the FDA product code for proctoscope. It is a Class II device, regulated under 21 CFR 876.1500 and reviewed by the Gastroenterology and Urology panel. FDA has cleared 2 510(k) submissions under GCF, from 2 different applicants. The average 510(k) review took 78 days (median 78). FDA has posted 1 recall for GCF devices, 1 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Proctoscope |
| 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 GCF clearance
Top GCF applicants
| Applicant | Clearances | Latest |
|---|---|---|
| KARL STORZ Endoscopy-America, Inc. | 1 | 1995-03-06 |
| C. Intl. | 1 | 1979-05-29 |
Most recent GCF clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K945209 | KARL STORZ Endoscopy-America, Inc. | PROCTOSCOPEA & ACCESSORIES, SIGMOIDOSCOPES & ACCESSORIES, PROCTOLOGY INSTRUMENTS | 1995-03-06 | 132 |
| K790856 | C. Intl. | PROCTOSCOPE #501 | 1979-05-29 | 25 |
Recalls for GCF devices
1 product recalls in 1 recall events; 1 initiated in the last five years and 1 still open. Most recent: 2023-10-24.
| Year | Recalls |
|---|---|
| 2023 | 1 |
Frequently asked questions
What is FDA product code GCF?
GCF is the FDA product code for proctoscope. It is a Class II device, regulated under 21 CFR 876.1500 and reviewed by the Gastroenterology and Urology panel.
What device class is GCF?
Class II, regulation 21 CFR 876.1500. Typical premarket route: 510(k).
How long does a 510(k) take for product code GCF?
Across 2 cleared submissions the average was 78 days from receipt to decision (median 78).
Which companies have the most GCF clearances?
KARL STORZ Endoscopy-America, Inc. (1); C. Intl. (1).
Have GCF devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2023-10-24.
Next steps
- Run an FDA pathway report with predicate devices for product code GCF
- Run a recall and safety report across every GCF manufacturer
- Watch product code GCF 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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