Cleared Traditional

K870698 - VAN-TEC PROSTATE BIOPSY NEEDLE
(FDA 510(k) Clearance)

Mar 1987
Decision
34d
Days
Class 1
Risk

K870698 is an FDA 510(k) clearance for the VAN-TEC PROSTATE BIOPSY NEEDLE. This device is classified as a Components, Wheelchair (Class I - General Controls, product code KNN).

Submitted by Van-Tec, Inc. (Spencer, US). The FDA issued a Cleared decision on March 25, 1987, 34 days after receiving the submission on February 19, 1987.

This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.3920.

Submission Details

510(k) Number K870698 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 19, 1987
Decision Date March 25, 1987
Days to Decision 34 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary

Device Classification

Product Code KNN — Components, Wheelchair
Device Class Class I - General Controls
CFR Regulation 21 CFR 890.3920