STONE RETRIEVAL BASKET— 510(k) K930349

Name: FDA 510(k) clearance K930349
Creator: U.S. Food and Drug Administration
Published: 1993-06-09

Substantially Equivalent

Endomedix

FDA 510(k) clearance K930349 for STONE RETRIEVAL BASKET, Substantially Equivalent on 1993-06-09. Applicant: Endomedix. Device class: 2.

Clearance details

Applicant: Endomedix
Product code: Code FFL
Device class: Class 2
Regulation: 21 CFR 876.4680
Advisory panel: Gastroenterology, Urology
Date received: 1993-01-25
Decision date: 1993-06-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Irvine, CA, US

Download summary PDF View on FDA.gov ↗

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

More clearances from Endomedix

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K934170 — ENDOMEDIX Y-ADAPTER1994-01-11
K934623 — ENDOSCOPIC VIDEO SYSTEM AND ENDOSCOPIC VIDEO CAMERA1993-12-02
K930499 — GRASPING FORCEPS FLEXIBLE STONE DISLODGER1993-08-16
K926004 — ENDOSCOPE AND ACCOSSORIES1993-02-10
K922837 — S1500 XENON LIGHT SOURCE1992-11-03

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.