FDA product code FGM: Probe And Director, Gastro-Urology
FGM is the FDA product code for probe and director, gastro-urology. It is a Class I device, regulated under 21 CFR 876.4730 and reviewed by the Gastroenterology and Urology panel. FDA has cleared 7 510(k) submissions under FGM, from 3 different applicants. The average 510(k) review took 105 days (median 122). FDA has posted 1 recall for FGM devices.
Classification
| Field | Value |
|---|---|
| Device name | Probe And Director, Gastro-Urology |
| Device class | Class I |
| Regulation | 21 CFR 876.4730 |
| Review panel | GU — Gastroenterology and Urology |
| Medical specialty | Gastroenterology, Urology |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every FGM clearance
Top FGM applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Regulatory & Marketing Services, Inc. | 3 | 1995-02-15 |
| Blue Torch Medical Technologies | 2 | 2004-09-21 |
| Uromed Corp. | 2 | 2001-02-01 |
Most recent FGM clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K041732 | Blue Torch Medical Technologies | CAVERMAP SURGICAL AID | 2004-09-21 | 88 |
| K031527 | Blue Torch Medical Technologies | MODIFICATION TO CAVERMAP SURGICAL AID | 2003-06-05 | 21 |
| K010098 | Uromed Corp. | MODIFICATION TO CAVERMAP SURGICAL AID | 2001-02-01 | 21 |
| K993436 | Uromed Corp. | CAVERMAP SURGICAL AID | 2000-02-11 | 122 |
| K944379 | Regulatory & Marketing Services, Inc. | ORION'S FOLEY CATHETERIZATION KIT WITH CATHETER AND BAG | 1995-02-15 | 161 |
Recalls for FGM devices
1 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2004-02-06.
Frequently asked questions
What is FDA product code FGM?
FGM is the FDA product code for probe and director, gastro-urology. It is a Class I device, regulated under 21 CFR 876.4730 and reviewed by the Gastroenterology and Urology panel.
What device class is FGM?
Class I, regulation 21 CFR 876.4730. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code FGM?
Across 7 cleared submissions the average was 105 days from receipt to decision (median 122).
Which companies have the most FGM clearances?
Regulatory & Marketing Services, Inc. (3); Blue Torch Medical Technologies (2); Uromed Corp. (2).
Have FGM devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2004-02-06.
Next steps
- Run an FDA pathway report with predicate devices for product code FGM
- Run a recall and safety report across every FGM manufacturer
- Watch product code FGM 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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