FDA Product Code
FDA Product Code FGM — Clearance Directory
- Device Class
- Class I
- Assigned Panel
- Gastroenterology, Urology
- 21 CFR Citation
- 876.4730
510(k) Clearances — 7 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K041732 | CAVERMAP SURGICAL AID | Blue Torch Medical Technologies | 2004-09-21 | Traditional | PDF ↗ |
| K031527 | MODIFICATION TO CAVERMAP SURGICAL AID | Blue Torch Medical Technologies | 2003-06-05 | Special | PDF ↗ |
| K010098 | MODIFICATION TO CAVERMAP SURGICAL AID | Uromed Corp. | 2001-02-01 | Special | PDF ↗ |
| K993436 | CAVERMAP SURGICAL AID | Uromed Corp. | 2000-02-11 | Traditional | PDF ↗ |
| K944384 | ORION'S URETHRAL CATHETERIZATION KIT WITHOUT BAG | Regulatory & Marketing Services, Inc. | 1995-02-15 | Traditional | PDF ↗ |
| K944379 | ORION'S FOLEY CATHETERIZATION KIT WITH CATHETER AND BAG | Regulatory & Marketing Services, Inc. | 1995-02-15 | Traditional | PDF ↗ |
| K944378 | ORION'S URETHRAL CATHETERIZATION KIT WITH CATHETER AND BAG | Regulatory & Marketing Services, Inc. | 1995-02-15 | Traditional | PDF ↗ |
Product code FGM · Class I · Gastroenterology, Urology. Data: openFDA.