Cleared Traditional

K760734 - REGULAR AND WIDE SKIN STAPLES (FDA 510(k) Clearance)

Nov 1976
Decision
36d
Days
Class 1
Risk

K760734 is an FDA 510(k) clearance for the REGULAR AND WIDE SKIN STAPLES. This device is classified as a Staple, Removable (skin) (Class I - General Controls, product code GDT).

Submitted by Ethicon, Inc. (Mchenry, US). The FDA issued a Cleared decision on November 3, 1976, 36 days after receiving the submission on September 28, 1976.

This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4760.

Submission Details

510(k) Number K760734 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 28, 1976
Decision Date November 03, 1976
Days to Decision 36 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary

Device Classification

Product Code GDT — Staple, Removable (skin)
Device Class Class I - General Controls
CFR Regulation 21 CFR 878.4760