HGS
2 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Catheter, Intrauterine And Introducer
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 884.2700
- Medical specialty
- Obstetrics/Gynecology
- Flags
- Third-party review eligible
- Adverse events (MAUDE)
- 1997: 6 · 2001: 1 · 2003: 4 · 2005: 2 · 2006: 4 · 2007: 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 |
|---|---|---|
| TRANSCERVICAL INTRAUTERINE KIT (K914387) | Telos Medical Corp. | 1991-12-30 |
| INTRAUTERINE CATHETER SET (K905812) | Epcom Medical Systems, Inc. | 1991-01-31 |
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Every clearance here is in the API, with alerts when new ones post.