GCZ
5 FDA 510(k) clearances · Product code
49 daysmedian time to decision
77 days90th percentile
5clearances measured
FDA profile
- Official device name
- Retainer, Surgical
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 878.4800
- Medical specialty
- General, Plastic Surgery
- Adverse events (MAUDE)
- 1999: 2 · 2003: 2 · 2004: 8
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 |
|---|---|---|
| JAIN GRAFT ASSIST (K904536) | Jain Surgical Equipment, Inc. | 1990-11-29 |
| ADAMS BREAST IMPLANT PROTECTOR (K893870) | Adept-Med Intl., Inc. | 1989-07-14 |
| MCNEALY-GLASSMAN VISCERA RETAINER #3202/3204/3206 (K870809) | Adept-Med Intl., Inc. | 1987-03-19 |
| VISECERA RETAINER (K802806) | Adept-Med Intl., Inc. | 1981-01-23 |
| CHILDREN'S HOSPITAL PEDIATRIC RETRACTOR (K801610) | Edward Weck, Inc. | 1980-08-04 |
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Every clearance here is in the API, with alerts when new ones post.