Cleared Traditional

K983536 - PROXIMATE CURVED AND STRAIGHT INTRALUMINAL STAPLERS

K983536 is an FDA 510(k) clearance for PROXIMATE CURVED AND STRAIGHT INTRALUMI..., manufactured by Ethicon Endo-Surgery, Inc.. The device is a Class 2 General & Plastic Surgery device with product code GDW cleared through the Traditional 510(k) pathway after a 70-day FDA review.

K983536 · Ethicon Endo-Surgery, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Dec 1998
Decision
70d
Days
Class 2
Risk

K983536 is an FDA 510(k) clearance for the PROXIMATE CURVED AND STRAIGHT INTRALUMINAL STAPLERS. Classified as Staple, Implantable (product code GDW), Class II - Special Controls.

Submitted by Ethicon Endo-Surgery, Inc. (Cincinnati, US). The FDA issued a Cleared decision on December 18, 1998 after a review of 70 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 - K983536

510(k) Number K983536 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 09, 1998
Decision Date December 18, 1998
Days to Decision 70 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
45d faster than avg
Panel avg: 115d · This submission: 70d
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 274
Devices cleared under the same product code (GDW) and FDA review panel - the closest regulatory comparables to K983536.
PROXIMATE HCS HEMORRHOIDAL CIRCULAR STAPLER AND ACCESSORIES
K991030 · Ethicon Endo-Surgery, Inc. · May 1999
FIXATION SYSTEM
K983318 · General Surgical Innovations · Mar 1999
AUTO SUTURE SITE MARKER CLIP
K983400 · United States Surgical, A Division of Tyco Healthc · Feb 1999
MODIFICATION TO REFLEX AEC LINEAR STAPLER/CUTTER
K980617 · Urohealth Systems, Inc. · Apr 1998
MICROMARK CLIP
K970817 · Biopsys Medical, Inc. · Sep 1997
SURGICAL STAPLE MARKER DEVICE (MODIFY)
K963015 · Biopsys Medical, Inc. · Oct 1996
K983536 · PROXIMATE CURVED AND STRAIGHT INTRALUMINAL STAPLERS
Download PDF FDA Summary Ethicon Endo-Surgery,…