Cleared Traditional

K943719 - VISISTAT STAPLER

K943719 is an FDA 510(k) clearance for VISISTAT STAPLER, manufactured by Pilling Weck, Inc.. The device is a Class 1 General & Plastic Surgery device with product code GDT cleared through the Traditional 510(k) pathway after a 23-day FDA review.

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

K943719 is an FDA 510(k) clearance for the VISISTAT STAPLER. Classified as Staple, Removable (skin) (product code GDT), Class I - General Controls.

Submitted by Pilling Weck, Inc. (Research Triangle Park, US). The FDA issued a Cleared decision on August 24, 1994 after a review of 23 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4760 - the FDA general and plastic surgery device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Pilling Weck, Inc. devices

FDA 510(k) Submission Details - K943719

510(k) Number K943719 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
92d faster than avg
Panel avg: 115d · This submission: 23d
Pathway characteristics
Predicate-based equivalence.

GDT Device Classification - Class 1, General Controls

Product Code GDT Staple, Removable (skin)
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 878.4760
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - GDT Staple, Removable (skin)

All 12
Devices cleared under the same product code (GDT) and FDA review panel - the closest regulatory comparables to K943719.
QUALTEX SKIN STAPLE EXTRACTOR
K911204 · Deroyal Industries, Inc. · May 1991
AUTO SUTURE(R) POLYMER SKIN GRAFT STAPLER*
K910586 · United States Surgical, A Division of Tyco Healthc · Mar 1991
APPOSE UNITY STERILE DISPOSABLE SKIN STAPLER
K900486 · Davis & Geck, Inc. · Apr 1990
SKIN STAPLE REMOVER WITH SPONGE STERILE DISPOSABLE
K861711 · Busse Hospital Disposables, Inc. · May 1986
V. MUELLER VITAL SKIN STAPLER
K851974 · American V. Mueller · Jun 1985
VISISTAT SKIN STAPLING DEVICE
K844837 · Edward Weck, Inc. · Jan 1985