Instrument, Cast Removal, Ac-Powered
An AC-powered cast removal instrument is an electrically powered device used to safely cut through and remove plaster or synthetic orthopedic casts without injury to the underlying skin, typically used by orthopedic healthcare practitioners. The device is FDA Class 1, the lowest risk category, requiring only general controls compliance without premarket notification. It carries product code LGH and is regulated under 21 CFR 888.5960 within the Orthopedic specialty. No special flags apply to this device.
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Basic Information
- Product Code
- LGH
- Device Class
- FDA class 1
- Regulation Number
- 888.5960
- Medical Specialty
- Orthopedic
- Review Panel
- OR
- Submission Type
- 4
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 9 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K932653 | SWISSTEK 2000(TM) CAST REMOVAL SYSTEM | Jan 28, 1994 | Substantially Equivalent | Carapace, Inc. |
| K901677 | CARAPACE PORTABLE CAST SAW, SWISS-EX CAST CUTTER | Apr 23, 1990 | Substantially Equivalent | Buckman Co., Inc. |
| K893380 | QCR SYSTEM I AND QCR SYSTEM II | Nov 16, 1989 | Substantially Equivalent | Bremer Mfg. & Tool Co., Inc. |
| K895861 | DELTA-TECH(TM) CAST REMOVAL SYSTEM | Oct 19, 1989 | Substantially Equivalent | Johnson & Johnson Professionals, Inc. |
| K873723 | PLASTER VACUUM, 230V MODEL NO. 4183-161 | Dec 10, 1987 | Substantially Equivalent | Martin Medical |
| K873721 | PLASTER VACUUM, 115V MODEL NO. 4183-160 | Dec 07, 1987 | Substantially Equivalent | Martin Medical |
| K873720 | CAST CUTTER, 230V MODEL NO. 4183-107 | Oct 02, 1987 | Substantially Equivalent | Martin Medical |
| K873719 | CAST CUTTER, 115V MODEL NO. 4183-106 | Oct 02, 1987 | Substantially Equivalent | Martin Medical |
| K820351 | CAST CUTTER/CAST SAW/INSTRUMENT | Mar 02, 1982 | Substantially Equivalent | Black & Decker(Tm) |
FEI Numbers
This FDA classification entry is associated with 37 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 37 registration numbers. Click on an entry to view related FDA registrations.