Cleared Traditional

MANIPLER DISPOSABLE SKIN STAPLER (K925526) - FDA 510(k) Clearance

Class I General & Plastic Surgery device.

K925526 · Matsutani Seisakusho Co. , Ltd. · General & Plastic Surgery device
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Jun 1993
Decision
234d
Days
Class 1
Risk

K925526 is an FDA 510(k) clearance for the MANIPLER DISPOSABLE SKIN STAPLER. Classified as Staple, Removable (skin) (product code GDT), Class I - General Controls.

Submitted by Matsutani Seisakusho Co. , Ltd. (Mahwah, US). The FDA issued a Cleared decision on June 24, 1993 after a review of 234 days - an extended review 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: 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.

View all Matsutani Seisakusho Co. , Ltd. devices

Submission Details

510(k) Number K925526 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 02, 1992
Decision Date June 24, 1993
Days to Decision 234 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
119d slower than avg
Panel avg: 115d · This submission: 234d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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 8
Devices cleared under the same product code (GDT) and FDA review panel - the closest regulatory comparables to K925526.
AUTO SUTURE(R) POLYMER SKIN GRAFT STAPLER*
K910586 · United States Surgical, A Division of Tyco Healthc · Mar 1991
VISISTAT SKIN STAPLING DEVICE
K844837 · Edward Weck, Inc. · Jan 1985
SKIN STAT II SKIN STAPLING MEDICAL DEVICE
K844838 · Edward Weck, Inc. · Jan 1985
VYDAX 525-550 & 5100 FLUOROTELOMER
K833357 · Ethicon, Inc. · Dec 1983
DISP. SKIN STAPLER REMOVALBLE SKINSTAPLE
K821024 · Howmedica Corp. · May 1982
SKIN STAPLE REMOVER #523770
K801444 · Edward Weck, Inc. · Jul 1980