LGH
9 FDA 510(k) clearances · Product code
22 daysmedian time to decision
240 days90th percentile
9clearances measured
FDA profile
- Official device name
- Instrument, Cast Removal, Ac-Powered
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 888.5960
- Medical specialty
- Orthopedic
- Adverse events (MAUDE)
- 2005: 4 · 2006: 4 · 2010: 6 · 2011: 23 · 2012: 6 · 2013: 12
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 |
|---|---|---|
| SWISSTEK 2000(TM) CAST REMOVAL SYSTEM (K932653) | Carapace, Inc. | 1994-01-28 |
| CARAPACE PORTABLE CAST SAW, SWISS-EX CAST CUTTER (K901677) | Buckman Co., Inc. | 1990-04-23 |
| QCR SYSTEM I AND QCR SYSTEM II (K893380) | Bremer Mfg. & Tool Co., Inc. | 1989-11-16 |
| DELTA-TECH(TM) CAST REMOVAL SYSTEM (K895861) | Johnson & Johnson Professionals, Inc. | 1989-10-19 |
| PLASTER VACUUM, 230V MODEL NO. 4183-161 (K873723) | Martin Medical | 1987-12-10 |
| PLASTER VACUUM, 115V MODEL NO. 4183-160 (K873721) | Martin Medical | 1987-12-07 |
| CAST CUTTER, 115V MODEL NO. 4183-106 (K873719) | Martin Medical | 1987-10-02 |
| CAST CUTTER, 230V MODEL NO. 4183-107 (K873720) | Martin Medical | 1987-10-02 |
| CAST CUTTER/CAST SAW/INSTRUMENT (K820351) | Black & Decker(Tm) | 1982-03-02 |
Track LGH automatically
Every clearance here is in the API, with alerts when new ones post.