Elevator, Surgical, General & Plastic Surgery
The Elevator, Surgical, for General and Plastic Surgery (product code GEG) is a manual handheld instrument used intraoperatively to separate or lift soft tissue and periosteum from underlying structures during general and plastic surgery procedures. It is classified as an FDA Class 1 device, the lowest risk category, subject to general controls with no premarket notification required. Regulated under 21 CFR 878.4800 and assigned to the General, Plastic Surgery specialty (SU), this instrument carries no special regulatory flags.
Basic Information
- Product Code
- GEG
- Device Class
- FDA class 1
- Regulation Number
- 878.4800
- Medical Specialty
- General, Plastic Surgery
- Review Panel
- SU
- Submission Type
- 4
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 12 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K891899 | ELEVATORS, VARIOUS TYPES | Apr 12, 1989 | Substantially Equivalent | ZINNANTI SURGICAL INSTRUMENTS, INC. |
| K891894 | ELEVATORS-COTTLE,MCKENTY,GOLDMAN,JOSEPH,CONVERSE | Apr 12, 1989 | Substantially Equivalent | ZINNANTI SURGICAL INSTRUMENTS, INC. |
| K890365 | SEPTUM ELEVATOR | Feb 03, 1989 | Substantially Equivalent | KINETIC MEDICAL PRODUCTS |
| K890253 | SURGICAL ELEVATOR | Jan 27, 1989 | Substantially Equivalent | KINETIC MEDICAL PRODUCTS |
| K890230 | LIGATURE NEEDLES | Jan 27, 1989 | Substantially Equivalent | KINETIC MEDICAL PRODUCTS |
| K872491 | 1.1 TWIST DRILLS AND 1.2 CORTICAL DRILLS | Jul 16, 1987 | Substantially Equivalent | MICRO-AIRE SURGICAL INSTRUMENTS, INC. |
| K870781 | ACROMED WALLIE-HEINIG DISECTOR/ELEVATORS | Mar 09, 1987 | Substantially Equivalent | BUCKMAN CO., INC. |
| K870591 | ELEVATOR, COBB SPINAL | Feb 26, 1987 | Substantially Equivalent | MILITARY ENGINEERING, INC. |
| K870126 | FEMUR WRENCH | Feb 03, 1987 | Substantially Equivalent | ORTHOPEDIC SYSTEMS, INC. |
| K864421 | RAYLOR(TM) PERIOSTEAL ELEVATORS | Nov 26, 1986 | Substantially Equivalent | CEDAR SURGICAL, INC. |
| K834176 | H.R. JAKOBI SURG. INSTRUMENTS 40/41 | Jan 27, 1984 | Substantially Equivalent | IMM ENTERPRISES LTD. |
| K781449 | HARRINGTON SPINAL ELEVATOR | Sep 27, 1978 | Substantially Equivalent | ORTHOPEDIC EQUIPMENT CO., INC. |
FEI Numbers
This FDA classification entry is associated with 228 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 228 registration numbers. Click on an entry to view related FDA registrations.