GLASSMAN-DORMIA GALLSTONE EXTRACTOR SET— 510(k) K811580

Name: FDA 510(k) clearance K811580
Creator: U.S. Food and Drug Administration
Published: 1981-06-26

Substantially Equivalent

Porges Catheter Corp.

FDA 510(k) clearance K811580 for GLASSMAN-DORMIA GALLSTONE EXTRACTOR SET, Substantially Equivalent on 1981-06-26. Applicant: Porges Catheter Corp.. Device class: 2.

Clearance details

Applicant: Porges Catheter Corp.
Product code: Code FFL
Device class: Class 2
Regulation: 21 CFR 876.4680
Advisory panel: Gastroenterology, Urology
Date received: 1981-06-05
Decision date: 1981-06-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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Recent devices under product code FFL

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K190492 — Peralta Stone Removal Catheter2019-07-18
K172299 — Accordion Piccolo Stone Management Device2017-09-19
K102887 — ACCORDION STONE MANAGEMENT DEVICE MODEL AC281205 AND AC38145102011-05-16
K082803 — COAXIAL ACCORDION STONE MANAGEMENT DEVICE, MODEL: COAC12005 - COA200152008-11-13
K052048 — ACCORDION2005-09-13

Adverse events under product code FFL

product code FFL

Death: 2
Injury: 270
Malfunction: 2,711
Other: 2
Total: 2,985

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.