Cleared Traditional

K911462 - SURGICAL TROCAR (FDA 510(k) Clearance)

K911462 · Applied Medical · Cardiovascular device

Apr 1991

Decision

19d

Days

Class 2

Risk

K911462 is an FDA 510(k) clearance for the SURGICAL TROCAR. This device is classified as a Trocar (Class II - Special Controls, product code DRC).

Submitted by Applied Medical (Bolton, US). The FDA issued a Cleared decision on April 22, 1991, 19 days after receiving the submission on April 3, 1991.

This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1390.

Submission Details

510(k) Number	K911462 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	April 03, 1991
Decision Date	April 22, 1991
Days to Decision	19 days
Submission Type	Traditional
Review Panel	Cardiovascular (CV)
Summary	-

Device Classification

Product Code	DRC - Trocar
Device Class	Class II - Special Controls
CFR Regulation	21 CFR 870.1390