FDA product code LGH: Instrument, Cast Removal, Ac-Powered
LGH is the FDA product code for instrument, cast removal, ac-powered. It is a Class I device, regulated under 21 CFR 888.5960 and reviewed by the Orthopedic panel. FDA has cleared 9 510(k) submissions under LGH, from 6 different applicants. The average 510(k) review took 77 days (median 22).
Classification
| Field | Value |
|---|---|
| Device name | Instrument, Cast Removal, Ac-Powered |
| Device class | Class I |
| Regulation | 21 CFR 888.5960 |
| Review panel | OR — Orthopedic |
| Medical specialty | Orthopedic |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every LGH clearance
Top LGH applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Martin Medical | 4 | 1987-12-10 |
| Carapace, Inc. | 1 | 1994-01-28 |
| Buckman Co., Inc. | 1 | 1990-04-23 |
| Bremer Mfg. & Tool Co., Inc. | 1 | 1989-11-16 |
| Johnson & Johnson Professionals, Inc. | 1 | 1989-10-19 |
1 more applicants have LGH clearances. See the full list in Caduvo.
Most recent LGH clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K932653 | Carapace, Inc. | SWISSTEK 2000(TM) CAST REMOVAL SYSTEM | 1994-01-28 | 240 |
| K901677 | Buckman Co., Inc. | CARAPACE PORTABLE CAST SAW, SWISS-EX CAST CUTTER | 1990-04-23 | 13 |
| K893380 | Bremer Mfg. & Tool Co., Inc. | QCR SYSTEM I AND QCR SYSTEM II | 1989-11-16 | 199 |
| K895861 | Johnson & Johnson Professionals, Inc. | DELTA-TECH(TM) CAST REMOVAL SYSTEM | 1989-10-19 | 16 |
| K873723 | Martin Medical | PLASTER VACUUM, 230V MODEL NO. 4183-161 | 1987-12-10 | 86 |
Recalls for LGH devices
openFDA lists no recalls for product code LGH.
Frequently asked questions
What is FDA product code LGH?
LGH is the FDA product code for instrument, cast removal, ac-powered. It is a Class I device, regulated under 21 CFR 888.5960 and reviewed by the Orthopedic panel.
What device class is LGH?
Class I, regulation 21 CFR 888.5960. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code LGH?
Across 9 cleared submissions the average was 77 days from receipt to decision (median 22).
Which companies have the most LGH clearances?
Martin Medical (4); Carapace, Inc. (1); Buckman Co., Inc. (1); Bremer Mfg. & Tool Co., Inc. (1); Johnson & Johnson Professionals, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code LGH
- Run a recall and safety report across every LGH manufacturer
- Watch product code LGH for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
All Orthopedic product codes · FDA product code lookup · 510(k) database search · 510(k) review times