Cleared Traditional

K894891 - IRRIGATOR STAND
(FDA 510(k) Clearance)

K894891 · Commercial Products & Engineering Co. · Obstetrics & Gynecology

Aug 1989

Decision

22d

Days

Class 2

Risk

K894891 is an FDA 510(k) clearance for the IRRIGATOR STAND. This device is classified as a Tenaculum, Uterine (Class II — Special Controls, product code HDC).

Submitted by Commercial Products & Engineering Co. (Grand Rapids, US). The FDA issued a Cleared decision on August 23, 1989, 22 days after receiving the submission on August 1, 1989.

This device falls under the Obstetrics & Gynecology FDA review panel. Regulated under 21 CFR 884.4530.

Submission Details

510(k) Number	K894891 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 01, 1989
Decision Date	August 23, 1989
Days to Decision	22 days
Submission Type	Traditional
Review Panel	Obstetrics & Gynecology (OB)
Summary	—