ANGIOMED URETERAL STONE DISLODGERS— 510(k) K854652

Name: FDA 510(k) clearance K854652
Creator: U.S. Food and Drug Administration
Published: 1986-02-10

Substantially Equivalent

Angiomed U.S., Inc.

FDA 510(k) clearance K854652 for ANGIOMED URETERAL STONE DISLODGERS, Substantially Equivalent on 1986-02-10. Applicant: Angiomed U.S., Inc.. Device class: 2.

Clearance details

Applicant: Angiomed U.S., Inc.
Product code: Code FFL
Device class: Class 2
Regulation: 21 CFR 876.4680
Advisory panel: Gastroenterology, Urology
Date received: 1985-11-19
Decision date: 1986-02-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Anaheim, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code FFL

view all

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 Angiomed U.S., Inc.

view all

K874771 — ANGIOMED INTRODUCING SETS1988-01-12
K874585 — ANGIOMED OSTY-CUT BONE BIOPSY NEEDLE1987-12-02
K864225 — ANGIOMED URETERAL D&M SETS/URETEROSCOPY GUID STENT1987-01-30
K863386 — VESICO SUPRAPUBIC BLADDER DRAINAGE & EXCHANGE SETS1986-10-24
K862805 — ANGIOMED VAC-U-CUT BIOPSY NEEDLE1986-09-29

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.