Cleared Traditional

APPOSE SKIN STAPLER & REMOVER (K823552) - FDA 510(k) Clearance

Class II General & Plastic Surgery device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K823552 · American Cyanamid Co. · General & Plastic Surgery device
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Jun 1983
Decision
197d
Days
Class 2
Risk

K823552 is an FDA 510(k) clearance for the APPOSE SKIN STAPLER & REMOVER. Classified as Staple, Implantable (product code GDW), Class II - Special Controls.

Submitted by American Cyanamid Co. (Mchenry, US). The FDA issued a Cleared decision on June 15, 1983 after a review of 197 days - an extended review cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4750 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

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Submission Details

510(k) Number K823552 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 30, 1982
Decision Date June 15, 1983
Days to Decision 197 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
82d slower than avg
Panel avg: 115d · This submission: 197d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code GDW Staple, Implantable
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4750
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General & Plastic Surgery devices follow this clearance model.

Regulatory Peers - GDW Staple, Implantable

All 108
Devices cleared under the same product code (GDW) and FDA review panel - the closest regulatory comparables to K823552.
AUTO SUTURE TITANIUM SURGICAL STAPLES
K855047 · United States Surgical, A Division of Tyco Healthc · Jan 1986
AUTO SUTURE POLY GIA SURGICAL STAPLER
K843603 · United States Surgical, A Division of Tyco Healthc · Oct 1984
DISPOSABLE LINEAR CUTTER
K843034 · Ethicon, Inc. · Sep 1984
AUTO SUTURE TA DISPOS-STAPLE CART
K830199 · United States Surgical, A Division of Tyco Healthc · Apr 1983
DISPOSABLE LINEAR STAPLER (LSF)
K822345 · Ethicon, Inc. · Sep 1982
DISPOSABLE LINEAR STAPLER-(LSR)
K821994 · Ethicon, Inc. · Aug 1982