FZW
8 FDA 510(k) clearances · Product code
100 daysmedian time to decision
169 days90th percentile
8clearances measured
FDA profile
- Official device name
- Expander, Surgical, Skin Graft
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 878.4800
- Medical specialty
- General, Plastic Surgery
- Adverse events (MAUDE)
- 2021: 554 · 2022: 510 · 2023: 605 · 2024: 443 · 2025: 440 · 2026: 251
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 |
|---|---|---|
| LB MEDICAL INFLATABLE TISSUE ELEVATOR/EXPANDER SYSTEM (K080158) | Lb Medical LLC | 2008-05-02 |
| BIRCOLL BALLOON DISSECTOR (K984448) | Wells Johnson Co. | 1999-01-28 |
| SPACEMAKER SURGICALBALLOON DISSECTOR/EXPANDER (K972109) | General Surgical Innovations | 1997-11-14 |
| AESCULAP SKIN GRAFT MESHER (K936186) | Aesculap, Inc. | 1994-03-10 |
| INAMED RUIZ-COHEN INTRAOPERATIVE TISSUE EXPANDER (K904265) | Inamed Development Co. | 1991-03-06 |
| SURGITEK INTRA-SPAN INTRAOPERATIVE TISSUE EXPANDER (K902349) | Surgitek | 1990-09-05 |
| MENTOR RAPID-SPAN (TM) TISSUE EXPANDER (K883303) | Mentor Corp. | 1988-08-26 |
| CUI, VERSAFIL(TM), STE(TM) TISSUE EXPANDER (K874276) | Cox-Uphuff Intl. | 1987-12-02 |
Track FZW automatically
Every clearance here is in the API, with alerts when new ones post.