Browse hierarchy: [Orthopedic (OR)](/submissions/OR) → [Subpart E — Surgical Devices](/submissions/OR/subpart-e%E2%80%94surgical-devices) → [21 CFR 888.5960](/submissions/OR/subpart-e%E2%80%94surgical-devices/888.5960) → LGH — Instrument, Cast Removal, Ac-Powered

# LGH · Instrument, Cast Removal, Ac-Powered

_Orthopedic · 21 CFR 888.5960 · Class 1_

**Canonical URL:** https://fda.innolitics.com/submissions/OR/subpart-e%E2%80%94surgical-devices/LGH

## Overview

- **Product Code:** LGH
- **Device Name:** Instrument, Cast Removal, Ac-Powered
- **Regulation:** [21 CFR 888.5960](/submissions/OR/subpart-e%E2%80%94surgical-devices/888.5960)
- **Device Class:** 1
- **Review Panel:** [Orthopedic](/submissions/OR)

## 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.

## Recent Cleared Devices (9 of 9)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K932653](https://fda.innolitics.com/submissions/OR/subpart-e%E2%80%94surgical-devices/LGH/K932653.md) | SWISSTEK 2000(TM) CAST REMOVAL SYSTEM | Carapace, Inc. | Jan 28, 1994 | SESE |
| [K901677](https://fda.innolitics.com/submissions/OR/subpart-e%E2%80%94surgical-devices/LGH/K901677.md) | CARAPACE PORTABLE CAST SAW, SWISS-EX CAST CUTTER | Buckman Co., Inc. | Apr 23, 1990 | SESE |
| [K893380](https://fda.innolitics.com/submissions/OR/subpart-e%E2%80%94surgical-devices/LGH/K893380.md) | QCR SYSTEM I AND QCR SYSTEM II | Bremer Mfg. & Tool Co., Inc. | Nov 16, 1989 | SESE |
| [K895861](https://fda.innolitics.com/submissions/OR/subpart-e%E2%80%94surgical-devices/LGH/K895861.md) | DELTA-TECH(TM) CAST REMOVAL SYSTEM | Johnson & Johnson Professionals, Inc. | Oct 19, 1989 | SESE |
| [K873723](https://fda.innolitics.com/submissions/OR/subpart-e%E2%80%94surgical-devices/LGH/K873723.md) | PLASTER VACUUM, 230V MODEL NO. 4183-161 | Martin Medical | Dec 10, 1987 | SESE |
| [K873721](https://fda.innolitics.com/submissions/OR/subpart-e%E2%80%94surgical-devices/LGH/K873721.md) | PLASTER VACUUM, 115V MODEL NO. 4183-160 | Martin Medical | Dec 7, 1987 | SESE |
| [K873720](https://fda.innolitics.com/submissions/OR/subpart-e%E2%80%94surgical-devices/LGH/K873720.md) | CAST CUTTER, 230V MODEL NO. 4183-107 | Martin Medical | Oct 2, 1987 | SESE |
| [K873719](https://fda.innolitics.com/submissions/OR/subpart-e%E2%80%94surgical-devices/LGH/K873719.md) | CAST CUTTER, 115V MODEL NO. 4183-106 | Martin Medical | Oct 2, 1987 | SESE |
| [K820351](https://fda.innolitics.com/submissions/OR/subpart-e%E2%80%94surgical-devices/LGH/K820351.md) | CAST CUTTER/CAST SAW/INSTRUMENT | Black & Decker(Tm) | Mar 2, 1982 | SESE |

## Top Applicants

- Martin Medical — 4 clearances
- Black & Decker(Tm) — 1 clearance
- Bremer Mfg. & Tool Co., Inc. — 1 clearance
- Buckman Co., Inc. — 1 clearance
- Carapace, Inc. — 1 clearance

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**Source:** [https://fda.innolitics.com/submissions/OR/subpart-e%E2%80%94surgical-devices/LGH](https://fda.innolitics.com/submissions/OR/subpart-e%E2%80%94surgical-devices/LGH)

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