Cleared Traditional

DISPOSABLE CIRCULAR STAPLER, MODELS WHY-25, WHY-29. WHY 32 (K100386) - FDA 510(k) Clearance

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

K100386 · Changzhou Waston Medical Appliance Co., Ltd. · General & Plastic Surgery device
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Optimized for regulatory review, auditing and printing
Mar 2010
Decision
13d
Days
Class 2
Risk

K100386 is an FDA 510(k) clearance for the DISPOSABLE CIRCULAR STAPLER, MODELS WHY-25, WHY-29. WHY 32. Classified as Staple, Implantable (product code GDW), Class II - Special Controls.

Submitted by Changzhou Waston Medical Appliance Co., Ltd. (Shanghai, CN). The FDA issued a Cleared decision on March 1, 2010 after a review of 13 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.

View all Changzhou Waston Medical Appliance Co., Ltd. devices

Submission Details

510(k) Number K100386 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 16, 2010
Decision Date March 01, 2010
Days to Decision 13 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
102d faster than avg
Panel avg: 115d · This submission: 13d
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 129
Devices cleared under the same product code (GDW) and FDA review panel - the closest regulatory comparables to K100386.
ETHICON ENDO-SURGERY 5MM LAPAROSCOPIC MULTI-FEED STAPLER
K102632 · Ethicon Endo-Surgery, Inc. · Oct 2010
COVIDIEN ENDO GIA RADIAL RELOAD WITH TRI-STAPLE TECHNOLOGY
K102291 · Covidien · Sep 2010
ETHICON SECURESTRAP 5MM ABSORBABLE STRAP FIXATION DEVICE, MODEL STRAP25
K093845 · Ethicon, Inc. · Apr 2010
BARD PERMAFIX FIXATION SYSTEM, MODEL 0113012, 0113014, 0113016, 0116018
K092483 · C.R. Bard, Inc. · Dec 2009
CONTOUR CURVED CUTTER STAPLER AND RELOADS, MODELS: CS40B, CS40G, CR40B, CR40G
K091322 · Ethicon Endo-Surgery, Inc. · Jun 2009
DAVOL ABSORBABLE FASTENER SYSTEM, MODEL (S) 0113080,0113081, 0113082, 0113084, 0113086, 0113087
K082396 · C.R. Bard, Inc. · Jan 2009