(ROTH)SPIRAL ROTATING PROSTATIC BIOPSY NEEDLE— 510(k) K863385

Name: FDA 510(k) clearance K863385
Creator: U.S. Food and Drug Administration
Published: 1986-11-04

Substantially Equivalent

Cook Urological, Inc.

FDA 510(k) clearance K863385 for (ROTH)SPIRAL ROTATING PROSTATIC BIOPSY NEEDLE, Substantially Equivalent on 1986-11-04. Applicant: Cook Urological, Inc.. Device class: 1.

Clearance details

Applicant: Cook Urological, Inc.
Product code: Code KNN
Device class: Class 1
Regulation: 21 CFR 890.3920
Advisory panel: Physical Medicine
Date received: 1986-09-03
Decision date: 1986-11-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Spencer, IN, US

Download summary PDF View on FDA.gov ↗

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