FDA Product Code
FDA Product Code FBM — Clearance Directory
- Device Class
- Class I
- Assigned Panel
- Gastroenterology, Urology
- 21 CFR Citation
- 876.5090
510(k) Clearances — 9 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K960400 | DIAMOND-TOUCH AND MICRO DIAMOND-TOUCH INSTRUMENTS/DIAMOND-LINE INSTRUMENTS/DIAMOND-PORT(ACCESS PARTS) | Snowden-Pencer | 1996-03-12 | Traditional | PDF ↗ |
| K932021 | ENTREE CANNULA FASCIA ANCHORS | Core Dynamics, Inc. | 1994-01-11 | Traditional | PDF ↗ |
| K911813 | ENTREE CANNULA | Core Dynamics, Inc. | 1991-07-19 | Traditional | PDF ↗ |
| K900964 | CANNULA AND TROCAR, 11MM | Solos Endoscopy, Inc. | 1990-04-18 | Traditional | PDF ↗ |
| K900965 | GS-4550 TROCAR ONLY, 11MM | Solos Endoscopy, Inc. | 1990-04-18 | Traditional | PDF ↗ |
| K900963 | GS-4350 TROCAR ONLY, 5.5MM | Solos Endoscopy, Inc. | 1990-04-18 | Traditional | PDF ↗ |
| K900962 | GS-4300 CANNULA AND TROCAR, 5.5MM | Solos Endoscopy, Inc. | 1990-04-18 | Traditional | PDF ↗ |
| K900961 | GS-4100 REDUCER SLEEVE, 5MM TO 3MM | Solos Endoscopy, Inc. | 1990-04-18 | Traditional | PDF ↗ |
| K900955 | GS-4000 REDUCER SLEEVE, 11MM TO 5MM | Solos Endoscopy, Inc. | 1990-04-18 | Traditional | PDF ↗ |
Product code FBM · Class I · Gastroenterology, Urology. Data: openFDA.