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FHM — Apparatus, Suturing, Stomach And Intestinal Class I

FDA Device Classification

FDA product code FHM covers "Apparatus, Suturing, Stomach And Intestinal", a Class I medical device regulated under 21 CFR 878.4800. Submissions are reviewed by the General, Plastic Surgery panel. At least 2 recent 510(k) clearances have been granted under this product code.

Classification Details

Product Code
FHM
Device Class
Class I
Regulation Number
878.4800
Submission Type
Review Panel
SU
Medical Specialty
General, Plastic Surgery
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K801590united states surgical, a division of tyco healthcAUTO SUTURE DISPOSABLE GIA SURG. STAPLERAugust 4, 1980
K801589united states surgical, a division of tyco healthcAUTO SUTURE DISP. 30, ETC. & SURG. STAPAugust 4, 1980

FDA data resources