Browse hierarchy: [General, Plastic Surgery (SU)](/submissions/SU) → [Subpart E — Surgical Devices](/submissions/SU/subpart-e%E2%80%94surgical-devices) → [21 CFR 878.4800](/submissions/SU/subpart-e%E2%80%94surgical-devices/878.4800) → GEG — Elevator, Surgical, General & Plastic Surgery

# GEG · Elevator, Surgical, General & Plastic Surgery

_General, Plastic Surgery · 21 CFR 878.4800 · Class 1_

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

## Overview

- **Product Code:** GEG
- **Device Name:** Elevator, Surgical, General & Plastic Surgery
- **Regulation:** [21 CFR 878.4800](/submissions/SU/subpart-e%E2%80%94surgical-devices/878.4800)
- **Device Class:** 1
- **Review Panel:** [General, Plastic Surgery](/submissions/SU)

## Identification

A manual surgical instrument for general use is a nonpowered, hand-held, or hand manipulated device, either reusable or disposable, intended to be used in various general surgical procedures. The device includes the applicator, clip applier, biopsy brush, manual dermabrasion brush, scrub brush, cannula, ligature carrier, chisel, clamp, contractor, curette, cutter, dissector, elevator, skin graft expander, file, forceps, gouge, instrument guide, needle guide, hammer, hemostat, amputation hook, ligature passing and knot-tying instrument, knife, mallet, disposable or reusable aspiration and injection needle, disposable or reusable suturing needle, osteotome, pliers, rasp, retainer, retractor, saw, scalpel blade, scalpel handle, one-piece scalpel, snare, spatula, stapler, disposable or reusable stripper, stylet, suturing apparatus for the stomach and intestine, measuring tape, and calipers. A surgical instrument that has specialized uses in a specific medical specialty is classified in separate regulations in parts 868 through 892 of this chapter.

## 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 § 878.9.

## Recent Cleared Devices (12 of 12)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K891899](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GEG/K891899.md) | ELEVATORS, VARIOUS TYPES | Zinnanti Surgical Instruments, Inc. | Apr 12, 1989 | SESE |
| [K891894](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GEG/K891894.md) | ELEVATORS-COTTLE,MCKENTY,GOLDMAN,JOSEPH,CONVERSE | Zinnanti Surgical Instruments, Inc. | Apr 12, 1989 | SESE |
| [K890365](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GEG/K890365.md) | SEPTUM ELEVATOR | Kinetic Medical Products | Feb 3, 1989 | SESE |
| [K890253](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GEG/K890253.md) | SURGICAL ELEVATOR | Kinetic Medical Products | Jan 27, 1989 | SESE |
| [K890230](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GEG/K890230.md) | LIGATURE NEEDLES | Kinetic Medical Products | Jan 27, 1989 | SESE |
| [K872491](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GEG/K872491.md) | 1.1 TWIST DRILLS AND 1.2 CORTICAL DRILLS | Micro-Aire Surgical Instruments, Inc. | Jul 16, 1987 | SESE |
| [K870781](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GEG/K870781.md) | ACROMED WALLIE-HEINIG DISECTOR/ELEVATORS | Buckman Co., Inc. | Mar 9, 1987 | SESE |
| [K870591](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GEG/K870591.md) | ELEVATOR, COBB SPINAL | Military Engineering, Inc. | Feb 26, 1987 | SESE |
| [K870126](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GEG/K870126.md) | FEMUR WRENCH | Orthopedic Systems, Inc. | Feb 3, 1987 | SESE |
| [K864421](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GEG/K864421.md) | RAYLOR(TM) PERIOSTEAL ELEVATORS | Cedar Surgical, Inc. | Nov 26, 1986 | SESE |
| [K834176](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GEG/K834176.md) | H.R. JAKOBI SURG. INSTRUMENTS 40/41 | Imm Enterprises , Ltd. | Jan 27, 1984 | SESE |
| [K781449](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GEG/K781449.md) | HARRINGTON SPINAL ELEVATOR | Orthopedic Equipment Co., Inc. | Sep 27, 1978 | SESE |

## Top Applicants

- Kinetic Medical Products — 3 clearances
- Zinnanti Surgical Instruments, Inc. — 2 clearances
- Buckman Co., Inc. — 1 clearance
- Cedar Surgical, Inc. — 1 clearance
- Imm Enterprises , Ltd. — 1 clearance

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

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