Cleared Traditional

HYSTEROSYS FLEXIBLE HYSTEROCOPE

K951946 · Ovamed Corp. · Obstetrics & Gynecology
Nov 1995
Decision
208d
Days
Class 2
Risk

About This 510(k) Submission

K951946 is an FDA 510(k) clearance for the HYSTEROSYS FLEXIBLE HYSTEROCOPE, a Hysteroscope (and Accessories) (Class II — Special Controls, product code HIH), submitted by Ovamed Corp. (Sunnyvale, US). The FDA issued a Cleared decision on November 20, 1995, 208 days after receiving the submission on April 26, 1995. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.1690.

Submission Details

510(k) Number K951946 FDA.gov
FDA Decision Cleared SESE
Date Received April 26, 1995
Decision Date November 20, 1995
Days to Decision 208 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Statement

Device Classification

Product Code HIH — Hysteroscope (and Accessories)
Device Class Class II — Special Controls
CFR Regulation 21 CFR 884.1690

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