LGH · Instrument, Cast Removal, Ac-Powered
Orthopedic · 21 CFR 888.5960 · Class 1
Overview
| Product Code | LGH |
|---|---|
| Device Name | Instrument, Cast Removal, Ac-Powered |
| Regulation | 21 CFR 888.5960 |
| Device Class | Class 1 |
| Review Panel | Orthopedic |
Identification
A cast removal instrument is an AC-powered, hand-held device intended to remove a cast from a patient. This generic type of device includes the electric cast cutter and cast vacuum.
Classification Rationale
Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 888.9.
Cleared Devices (9)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K932653 | SWISSTEK 2000(TM) CAST REMOVAL SYSTEM | Carapace, Inc. | Jan 28, 1994 | SESE |
| K901677 | CARAPACE PORTABLE CAST SAW, SWISS-EX CAST CUTTER | Buckman Co., Inc. | Apr 23, 1990 | SESE |
| K893380 | QCR SYSTEM I AND QCR SYSTEM II | Bremer Mfg. & Tool Co., Inc. | Nov 16, 1989 | SESE |
| K895861 | DELTA-TECH(TM) CAST REMOVAL SYSTEM | Johnson & Johnson Professionals, Inc. | Oct 19, 1989 | SESE |
| K873723 | PLASTER VACUUM, 230V MODEL NO. 4183-161 | Martin Medical | Dec 10, 1987 | SESE |
| K873721 | PLASTER VACUUM, 115V MODEL NO. 4183-160 | Martin Medical | Dec 7, 1987 | SESE |
| K873720 | CAST CUTTER, 230V MODEL NO. 4183-107 | Martin Medical | Oct 2, 1987 | SESE |
| K873719 | CAST CUTTER, 115V MODEL NO. 4183-106 | Martin Medical | Oct 2, 1987 | SESE |
| K820351 | CAST CUTTER/CAST SAW/INSTRUMENT | Black & Decker(Tm) | Mar 2, 1982 | SESE |
Top Applicants
- Martin Medical — 4 clearances
- Johnson & Johnson Professionals, Inc. — 1 clearance
- Carapace, Inc. — 1 clearance
- Buckman Co., Inc. — 1 clearance
- Bremer Mfg. & Tool Co., Inc. — 1 clearance
