STONE BASKET— 510(k) K914505

Name: FDA 510(k) clearance K914505
Creator: U.S. Food and Drug Administration
Published: 1991-12-09

Substantially Equivalent

Surgitek Medical Engineering Corp.

FDA 510(k) clearance K914505 for STONE BASKET, Substantially Equivalent on 1991-12-09. Applicant: Surgitek Medical Engineering Corp.. Device class: 2.

Clearance details

Applicant: Surgitek Medical Engineering Corp.
Product code: Code FFL
Device class: Class 2
Regulation: 21 CFR 876.4680
Advisory panel: Gastroenterology, Urology
Date received: 1991-10-09
Decision date: 1991-12-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Racine, WI, 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 Surgitek Medical Engineering Corp.

view all

K914504 — CYTOLOGY BRUSH1992-02-18
K914495 — E.R.C.P. CATHETER1992-01-30
K914497 — BIOPSY FORCEPS1992-01-03
K914496 — SCLEROTHERAPY NEEDLE1991-12-05
K914503 — GRASPING FORCEPS1991-12-05

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.