Cleared Traditional

K974137 - UROMED NEEDLE GRASPER (FDA 510(k) Clearance)

Class II Gastroenterology & Urology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

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

Submission Details

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.

Device Classification

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 69
Devices cleared under the same product code (OCW) and FDA review panel - the closest regulatory comparables to K974137.
Endomina EZFuse system
K252400 · Endo Tools Therapeutics S.A. · Feb 2026
SimpleStitch Suturing System
K243750 · Envision Endoscopy · Apr 2025
MaxTack™ Motorized Fixation Device
K231240 · Covidien · Sep 2023
MedicloseTM System
K213271 · Health Value Creation B.V., Trading AS Corporis Medical · Aug 2023
OverStitch NXT Endoscopic Suturing System
K231553 · Apollo Endosurgery, Inc. · Jun 2023