Cleared Traditional

K902242 - ENDOCERVICAL ASPIRATOR
(FDA 510(k) Clearance)

Oct 1990
Decision
144d
Days
Class 2
Risk

K902242 is an FDA 510(k) clearance for the ENDOCERVICAL ASPIRATOR. This device is classified as a Aspirator, Endocervical (Class II - Special Controls, product code HFC).

Submitted by Innovative Medical Products, Inc. (Slidell, US). The FDA issued a Cleared decision on October 9, 1990, 144 days after receiving the submission on May 18, 1990.

This device falls under the Obstetrics & Gynecology FDA review panel. Regulated under 21 CFR 884.1050.

Submission Details

510(k) Number K902242 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 18, 1990
Decision Date October 09, 1990
Days to Decision 144 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary

Device Classification

Product Code HFC — Aspirator, Endocervical
Device Class Class II - Special Controls
CFR Regulation 21 CFR 884.1050

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