FDA Product Code
FDA Product Code GBT — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Gastroenterology, Urology
- 21 CFR Citation
- 876.5980
510(k) Clearances — 3 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K941391 | INFLATABLE RETENTION CUFF SPECULUM | Innovatec Medical Corp. | 1994-10-20 | Traditional | PDF ↗ |
| K924549 | TRI-MED QUICK-STEP(TM) RECTAL TUBE | Tri-Med Specialties, Inc. | 1994-02-10 | Traditional | PDF ↗ |
| K890466 | SIGMOID TONOMITOR | Tonometrics, Inc. | 1989-04-21 | Traditional | PDF ↗ |
Product code GBT · Class II · Gastroenterology, Urology. Data: openFDA.