FDA Product Code
FDA Product Code FDE — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Gastroenterology, Urology
- 21 CFR Citation
- 876.1500
510(k) Clearances — 4 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K955717 | ENDOSCOPE INTRODUCER KIT | Mitsubishi Cable America, Inc. | 1996-04-18 | Traditional | PDF ↗ |
| K950924 | ASLAN KNOT PUSHER | Aslan Medical Technologies, Ltd. | 1995-03-14 | Traditional | PDF ↗ |
| K942677 | GEENEN/ZEBRA GUIDELINES | Boston Scientific Corp | 1994-07-21 | Traditional | PDF ↗ |
| K912443 | CANDELA INTRODUCER SHEATH SYSTEM | Candela Laser Corp. | 1991-08-16 | Traditional | PDF ↗ |
Product code FDE · Class II · Gastroenterology, Urology. Data: openFDA.