Cleared Traditional

K931103 - STRYKER STAPLER SYSTEM

K931103 is the FDA 510(k) clearance for STRYKER STAPLER SYSTEM by Stryker Endoscopy. It is a Class 2 General & Plastic Surgery device (product code GDW) cleared through the Traditional 510(k) pathway after a 223-day FDA review.

K931103 · Stryker Endoscopy · General & Plastic Surgery device
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Oct 1993
Decision
223d
Days
Class 2
Risk

K931103 is an FDA 510(k) clearance for the STRYKER STAPLER SYSTEM. Classified as Staple, Implantable (product code GDW), Class II - Special Controls.

Submitted by Stryker Endoscopy (San Jose, US). The FDA issued a Cleared decision on October 12, 1993 after a review of 223 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.

View all Stryker Endoscopy devices

Submission Details

510(k) Number K931103 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 03, 1993
Decision Date October 12, 1993
Days to Decision 223 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
108d slower than avg
Panel avg: 115d · This submission: 223d
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 157
Devices cleared under the same product code (GDW) and FDA review panel - the closest regulatory comparables to K931103.
PROXIMATE CURVED AND STRAIGHT INTRALUMINAL STAPLERS
K983536 · Ethicon Endo-Surgery, Inc. · Dec 1998
AUTO SUTURE* MODIFIED LINEAR STAPLER**
K952239 · United States Surgical, A Division of Tyco Healthc · Oct 1995
SURGICAL STAPLE
K942606 · United States Surgical, A Division of Tyco Healthc · Aug 1994
ENDOPATH ILS ENDOSCOPIC CIRCULAR STAPLER
K920752 · Ethicon, Inc. · Aug 1992
HEM-O-LOK -- MODIFICATION
K922186 · Linvatec Corp. · Aug 1992
3M PRECISE BRAND INTERNAL SURGICAL STAPLES
K921051 · 3M Health Care, Ltd. · Jul 1992