Cleared Traditional

K811580 - GLASSMAN-DORMIA GALLSTONE EXTRACTOR SET

K811580 is the FDA 510(k) clearance for GLASSMAN-DORMIA GALLSTONE EXTRACTOR SET by Porges Catheter Corp.. It is a Class 2 Gastroenterology & Urology device (product code FFL) cleared through the Traditional 510(k) pathway after a 21-day FDA review.

K811580 · Porges Catheter Corp. · Gastroenterology & Urology device
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Jun 1981
Decision
21d
Days
Class 2
Risk

K811580 is an FDA 510(k) clearance for the GLASSMAN-DORMIA GALLSTONE EXTRACTOR SET. Classified as Dislodger, Stone, Basket, Ureteral, Metal (product code FFL), Class II - Special Controls.

Submitted by Porges Catheter Corp. (Mchenry, US). The FDA issued a Cleared decision on June 26, 1981 after a review of 21 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.4680 - 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 Porges Catheter Corp. devices

Submission Details

510(k) Number K811580 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 05, 1981
Decision Date June 26, 1981
Days to Decision 21 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
109d faster than avg
Panel avg: 130d · This submission: 21d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FFL Dislodger, Stone, Basket, Ureteral, Metal
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.4680
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 - FFL Dislodger, Stone, Basket, Ureteral, Metal

All 27
Devices cleared under the same product code (FFL) and FDA review panel - the closest regulatory comparables to K811580.
WILSON-COOK STONE EXTRACTOR
K851965 · Wilson-Cook Medical, Inc. · Jul 1985
URETERAL DILATOR & URETERAL STONE DISLODGER
K850954 · American Edwards Laboratories · Apr 1985
SEGURA BASKET
K841942 · Van-Tec, Inc. · Jul 1984
STONE DISLODGER
K800608 · G.D. Searle and Co. · Apr 1980
STONE AND RETRIEVAL BASKET
K792344 · Mill-Rose Laboratory · Dec 1979