GBT
3 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Catheter, Rectal
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.5980
- Medical specialty
- Gastroenterology, Urology
- Flags
- Third-party review eligible
- Adverse events (MAUDE)
- 1994: 1 · 1998: 1 · 2001: 1 · 2002: 3 · 2003: 3 · 2005: 2
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| INFLATABLE RETENTION CUFF SPECULUM (K941391) | Innovatec Medical Corp. | 1994-10-20 |
| TRI-MED QUICK-STEP(TM) RECTAL TUBE (K924549) | Tri-Med Specialties, Inc. | 1994-02-10 |
| SIGMOID TONOMITOR (K890466) | Tonometrics, Inc. | 1989-04-21 |
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Every clearance here is in the API, with alerts when new ones post.