Cleared Traditional

K925526 - MANIPLER DISPOSABLE SKIN STAPLER

K925526 is an FDA 510(k) clearance for MANIPLER DISPOSABLE SKIN STAPLER, manufactured by Matsutani Seisakusho Co. , Ltd.. The device is a Class 1 General & Plastic Surgery device with product code GDT cleared through the Traditional 510(k) pathway after a 234-day FDA review.

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

FDA 510(k) Submission Details - K925526

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.

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 14
Devices cleared under the same product code (GDT) and FDA review panel - the closest regulatory comparables to K925526.
STAPLE REMOVAL KIT
K963234 · Continental Medical Laboratories, Inc. · Oct 1996
SKIN STAPLE REMOVER KIT
K915430 · Cypress Medical Products, Ltd. · Feb 1992
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