Cleared Traditional

K911262 - DISPOSABLE SPECIMEN BAG W/CANNULA AND INTRODUCER
(FDA 510(k) Clearance)

K911262 · Ethicon, Inc. · General & Plastic Surgery device

Jun 1991

Decision

90d

Days

Class 1

Risk

K911262 is an FDA 510(k) clearance for the DISPOSABLE SPECIMEN BAG W/CANNULA AND INTRODUCER. This device is classified as a Cannula, Surgical, General & Plastic Surgery (Class I - General Controls, product code GEA).

Submitted by Ethicon, Inc. (Somerville, US). The FDA issued a Cleared decision on June 20, 1991, 90 days after receiving the submission on March 22, 1991.

This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4800.

Submission Details

510(k) Number	K911262 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	March 22, 1991
Decision Date	June 20, 1991
Days to Decision	90 days
Submission Type	Traditional
Review Panel	General & Plastic Surgery (SU)
Summary	—