Cleared Traditional

K102931 - G-CINCH SUTURE GRASPER

K102931 is an FDA 510(k) clearance for G-CINCH SUTURE GRASPER, manufactured by Usgi Medical. The device is a Class 2 Gastroenterology & Urology device with product code OCW cleared through the Traditional 510(k) pathway after a 87-day FDA review.

K102931 · Usgi Medical · Gastroenterology & Urology device
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Dec 2010
Decision
87d
Days
Class 2
Risk

K102931 is an FDA 510(k) clearance for the G-CINCH SUTURE GRASPER. Classified as Endoscopic Tissue Approximation Device (product code OCW), Class II - Special Controls.

Submitted by Usgi Medical (San Clemente, US). The FDA issued a Cleared decision on December 30, 2010 after a review of 87 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 Usgi Medical devices

FDA 510(k) Submission Details - K102931

510(k) Number K102931 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 04, 2010
Decision Date December 30, 2010
Days to Decision 87 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
44d faster than avg
Panel avg: 131d · This submission: 87d
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 62
Devices cleared under the same product code (OCW) and FDA review panel - the closest regulatory comparables to K102931.
WECK EFX ENDO FASCIAL CLOSURE SYSTEM
K132362 · Teleflexmedical, Inc. · Oct 2013
ACE STAPLER AND CARTRIDGE
K120147 · Barosense, Inc. · Feb 2012
ACE STAPLER AND CARTRIDGE
K110829 · Barosense, Inc. · Jun 2011
AXIOM FASCIAL CLOSURE SYSTEM
K103412 · Axiom Technology Partners, LLC · Dec 2010
MINI-TONG
K101101 · Mini Lap Technologies, Inc. · Jul 2010
ACE STAPLER, MODEL F0031
K082044 · Barosense, Inc. · May 2010