FDA Product Code
FDA Product Code FDG — Clearance Directory
- Device Class
- Class I
- Assigned Panel
- Gastroenterology, Urology
- 21 CFR Citation
- 876.4530
510(k) Clearances — 2 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K964561 | ENDOLUMINA II TRANSILLUMINATION SYSTEM 56FR E-5630, 50FR E-5030 AND 40FR E-4020, ENDOLUMINA II DETACHABLE TIPS, 56FR, TA | Bioenterics Corp. | 1997-02-11 | Traditional | PDF ↗ |
| K945421 | CHAKOFF ENDOSCOPY | Stephen Chakoff, Inc. | 1994-12-23 | Traditional | PDF ↗ |
Product code FDG · Class I · Gastroenterology, Urology. Data: openFDA.