Cleared Traditional

K935822 - PHASE I CURETTE
(FDA 510(k) Clearance)

K935822 · Phase I Corp. · Obstetrics & Gynecology device

Apr 1994

Decision

146d

Days

Class 1

Risk

K935822 is an FDA 510(k) clearance for the PHASE I CURETTE. This device is classified as a Curette, Uterine (Class I - General Controls, product code HCY).

Submitted by Phase I Corp. (Norwalk, US). The FDA issued a Cleared decision on April 28, 1994, 146 days after receiving the submission on December 3, 1993.

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

Submission Details

510(k) Number	K935822 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	December 03, 1993
Decision Date	April 28, 1994
Days to Decision	146 days
Submission Type	Traditional
Review Panel	Obstetrics & Gynecology (OB)
Summary	Statement