Cleared Traditional

K921464 - CAT.#40100, 40102, 40104 & 40106 YANKAUER SUCT INT
(FDA 510(k) Clearance)

K921464 · Trinity Laboratories, Inc. · General & Plastic Surgery device

May 1992

Decision

39d

Days

Class 1

Risk

K921464 is an FDA 510(k) clearance for the CAT.#40100, 40102, 40104 & 40106 YANKAUER SUCT INT. This device is classified as a Catheter, Continuous Irrigation (Class I - General Controls, product code GBQ).

Submitted by Trinity Laboratories, Inc. (Salisbury, US). The FDA issued a Cleared decision on May 5, 1992, 39 days after receiving the submission on March 27, 1992.

This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4200.

Submission Details

510(k) Number	K921464 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	March 27, 1992
Decision Date	May 05, 1992
Days to Decision	39 days
Submission Type	Traditional
Review Panel	General & Plastic Surgery (SU)
Summary	Statement