Cleared Traditional

K974137 - UROMED NEEDLE GRASPER

K974137 is an FDA 510(k) clearance for UROMED NEEDLE GRASPER, manufactured by Uromed Corp.. The device is a Class 2 Gastroenterology & Urology device with product code OCW cleared through the Traditional 510(k) pathway after a 88-day FDA review.

K974137 · Uromed Corp. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 1998
Decision
88d
Days
Class 2
Risk

K974137 is an FDA 510(k) clearance for the UROMED NEEDLE GRASPER. Classified as Endoscopic Tissue Approximation Device (product code OCW), Class II - Special Controls.

Submitted by Uromed Corp. (Needham, US). The FDA issued a Cleared decision on January 30, 1998 after a review of 88 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.1500 - the FDA gastroenterology and urology 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 Uromed Corp. devices

FDA 510(k) Submission Details - K974137

510(k) Number K974137 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 03, 1997
Decision Date January 30, 1998
Days to Decision 88 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
42d faster than avg
Panel avg: 130d · This submission: 88d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

OCW Device Classification - Class 2, Special Controls

Product Code OCW Endoscopic Tissue Approximation Device
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.1500
Definition To Aid In Endoscopically Placing Sutures, Staples, Clips, And Other Fastening Tools Through Tissue.
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 Gastroenterology & Urology devices follow this clearance model.

Regulatory Peers - OCW Endoscopic Tissue Approximation Device

All 38
Devices cleared under the same product code (OCW) and FDA review panel - the closest regulatory comparables to K974137.
ENDOPATH ETS45, ETS FLEX45, ETS COMPACT-FLEX45 LINEAR CUTTERS, ETS FLEX45 AND ETS COMPACT-FLEX45 NO-KNIFE ARTICULATING
K002398 · Ethicon Endo-Surgery, Inc. · Nov 2000
SMITH & NEPHEW SUTURELOK, MODEL 7207321
K000717 · Smith & Nephew, Inc. · Mar 2000
ENDOPATH EZ45 ENDOSCOPIC LINEAR CUTTER
K980815 · Ethicon Endo-Surgery, Inc. · May 1998
INNOVASIVE DEVICES Y-KNOT SUTURE CLIP
K973313 · Innovasive Devices, Inc. · Dec 1997
ENDOPATH EZ45 ENDOSCOPIC LINEAR CUTTER AND THE ENDOPATH EZ45 NO KNIFE ENDOSCOPIC LINEAR STAPLER
K970720 · Ethicon Endo-Surgery, Inc. · Jun 1997
AUTO SUTURE* MODIFIED ENDOSCOPIC FASCIA STAPLER** DEVICE
K963999 · United States Surgical, A Division of Tyco Healthc · Nov 1996