ACCU-PATH— 510(k) K935250

Name: FDA 510(k) clearance K935250
Creator: U.S. Food and Drug Administration
Published: 1994-01-21

Substantially Equivalent

Cox Medical Ent., Inc.

FDA 510(k) clearance K935250 for ACCU-PATH, Substantially Equivalent on 1994-01-21. Applicant: Cox Medical Ent., Inc.. Device class: 1.

Clearance details

Applicant: Cox Medical Ent., Inc.
Product code: Code FCL
Device class: Class 1
Regulation: 21 CFR 876.1075
Advisory panel: Gastroenterology, Urology
Date received: 1993-11-01
Decision date: 1994-01-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Ventura, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code FCL

view all

K032092 — OLYMPUS XCYF-TP3 CYSTOFIBERSCOPE/NEPHROFIBERSCOPE2003-07-16
K973611 — SPECTRASCIENCE REUSABLE BIOPSY FORCEPS1997-12-02
K971315 — AUXILIARY INSTRUMENTS FOR URS1997-09-15
K964120 — INJECTO FLUSH1996-12-30
K963517 — SPECTRA SCIENCE BIOPSY FORCEPS1996-12-02

More clearances from Cox Medical Ent., Inc.

view all

K946360 — MODULAR BIOPSY FORCEP1995-03-06
K950689 — UCB1995-03-06
K941464 — BASICS ENDOSCOPY SYSTEM1994-08-05
K940911 — BASICS ENDOSCOPY SYSTEM1994-05-16
K932790 — THERMAL OPTION1994-01-28

Adverse events under product code FCL

product code FCL

Death: 5
Total: 5

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.