Apparatus, Suturing, Stomach And Intestinal
The Stomach and Intestinal Suturing Apparatus is a surgical device or set of instruments used to place sutures in the walls of the stomach or intestines during gastrointestinal surgical procedures such as anastomoses or repairs. It is classified as FDA Class 1, the lowest risk category, subject only to general controls. The product code is FHM, regulated under 21 CFR 878.4800, within the General, Plastic Surgery specialty.
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Basic Information
- Product Code
- FHM
- 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 2 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K801590 | AUTO SUTURE DISPOSABLE GIA SURG. STAPLER | Aug 04, 1980 | Substantially Equivalent | United States Surgical, A Division of Tyco Healthc |
| K801589 | AUTO SUTURE DISP. 30, ETC. & SURG. STAP | Aug 04, 1980 | Substantially Equivalent | United States Surgical, A Division of Tyco Healthc |
FEI Numbers
This FDA classification entry is associated with 17 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 17 registration numbers. Click on an entry to view related FDA registrations.