Cleared Traditional

VISISTAT STAPLER

K943719 · Pilling Weck, Inc. · General & Plastic Surgery
Aug 1994
Decision
23d
Days
Class 1
Risk

About This 510(k) Submission

K943719 is an FDA 510(k) clearance for the VISISTAT STAPLER, a Staple, Removable (skin) (Class I — General Controls, product code GDT), submitted by Pilling Weck, Inc. (Research Triangle Park, US). The FDA issued a Cleared decision on August 24, 1994, 23 days after receiving the submission on August 1, 1994. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4760.

Submission Details

510(k) Number K943719 FDA.gov
FDA Decision Cleared SESE
Date Received August 01, 1994
Decision Date August 24, 1994
Days to Decision 23 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement

Device Classification

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

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