Cleared Traditional

K101378 - FRANKENMAN SURGICAL STAPLERS

K101378 is an FDA 510(k) clearance for FRANKENMAN SURGICAL STAPLERS, manufactured by Suzhou Frankenman Medical Equipment Co., Ltd.. The device is a Class 2 General & Plastic Surgery device with product code GDW cleared through the Traditional 510(k) pathway after a 43-day FDA review.

K101378 · Suzhou Frankenman Medical Equipment Co., Ltd. · General & Plastic Surgery device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jun 2010
Decision
43d
Days
Class 2
Risk

K101378 is an FDA 510(k) clearance for the FRANKENMAN SURGICAL STAPLERS. Classified as Staple, Implantable (product code GDW), Class II - Special Controls.

Submitted by Suzhou Frankenman Medical Equipment Co., Ltd. (Austin, US). The FDA issued a Cleared decision on June 29, 2010 after a review of 43 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K101378

510(k) Number K101378 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 17, 2010
Decision Date June 29, 2010
Days to Decision 43 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
72d faster than avg
Panel avg: 115d · This submission: 43d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GDW Device Classification - Class 2, Special Controls

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 281
Devices cleared under the same product code (GDW) and FDA review panel - the closest regulatory comparables to K101378.
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K101378 · FRANKENMAN SURGICAL STAPLERS
Download PDF FDA Summary Suzhou Frankenman Med…