FDA product code FCC: Endoscopic Magnetic Retriever
FCC is the FDA product code for endoscopic magnetic retriever. It is a Class II device, regulated under 21 CFR 876.1500 and reviewed by the Gastroenterology and Urology panel. FDA has cleared 3 510(k) submissions under FCC, from 3 different applicants. The average 510(k) review took 73 days (median 48).
Definition
to endoscopically retrieve magnetic foreign objects
Classification
| Field | Value |
|---|---|
| Device name | Endoscopic Magnetic Retriever |
| 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 FCC clearance
Top FCC applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Olympus Corp. | 1 | 1991-03-21 |
| Brimfield Scientific Instruments | 1 | 1984-09-26 |
| Mr Associates, Inc. | 1 | 1980-05-08 |
Most recent FCC clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K904668 | Olympus Corp. | IE MAGNETIC EXTRACTOR | 1991-03-21 | 157 |
| K843135 | Brimfield Scientific Instruments | BRIMFIELD CANNULATED MAGNETIC RETRIEVER | 1984-09-26 | 48 |
| K800971 | Mr Associates, Inc. | M.R. ASSOC. MAGNETIC EXTRACTOR | 1980-05-08 | 15 |
Recalls for FCC devices
openFDA lists no recalls for product code FCC.
Frequently asked questions
What is FDA product code FCC?
FCC is the FDA product code for endoscopic magnetic retriever. It is a Class II device, regulated under 21 CFR 876.1500 and reviewed by the Gastroenterology and Urology panel.
What device class is FCC?
Class II, regulation 21 CFR 876.1500. Typical premarket route: 510(k).
How long does a 510(k) take for product code FCC?
Across 3 cleared submissions the average was 73 days from receipt to decision (median 48).
Which companies have the most FCC clearances?
Olympus Corp. (1); Brimfield Scientific Instruments (1); Mr Associates, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code FCC
- Run a recall and safety report across every FCC manufacturer
- Watch product code FCC 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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