Applier, Staple, Surgical,
The Applier, Staple, Surgical (product code GEF) is a manual surgical instrument used to deploy surgical staples during general and plastic surgery procedures, serving as an alternative to sutures for tissue approximation and wound closure. It is classified as an FDA Class 1 device, representing the lowest risk tier, subject to general controls with no requirement for premarket notification. Regulated under 21 CFR 878.4800 within the General, Plastic Surgery specialty (SU), this device carries no special flags for implantation, life support, GMP exemption, or third-party review eligibility.
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Basic Information
- Product Code
- GEF
- 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 4 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K933508 | REFLEX SDD SURGICAL STAPLER | Nov 23, 1993 | Substantially Equivalent | Richard-Allan Medical |
| K915670 | MICROAIRE MODEL 2600 | Mar 18, 1992 | Substantially Equivalent | Microaire |
| K854568 | V. MUELLER PNEUMO-INTESTINAL 15 VASCULAR & 30 STAP | Dec 02, 1985 | Substantially Equivalent | American V. Mueller |
| K823888 | 3M FRASCIA STAPLING SYSTEM | Jan 09, 1983 | Substantially Equivalent | 3M Company |
FEI Numbers
This FDA classification entry is associated with 28 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 28 registration numbers. Click on an entry to view related FDA registrations.