Cleared Traditional

MICROSPAN HYSTEROSCOPE

K961688 · Imagyn Medical, Inc. · Obstetrics & Gynecology
Oct 1996
Decision
167d
Days
Class 2
Risk

About This 510(k) Submission

K961688 is an FDA 510(k) clearance for the MICROSPAN HYSTEROSCOPE, a Hysteroscope (and Accessories) (Class II — Special Controls, product code HIH), submitted by Imagyn Medical, Inc. (Laguna Niguel, US). The FDA issued a Cleared decision on October 15, 1996, 167 days after receiving the submission on May 1, 1996. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.1690.

Submission Details

510(k) Number K961688 FDA.gov
FDA Decision Cleared SESE
Date Received May 01, 1996
Decision Date October 15, 1996
Days to Decision 167 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Summary PDF

Device Classification

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

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