Cleared Abbreviated

GIMMI ALPHA HYSTEROSCOPES & ACCESSORIES, MODELS E.8XXX.XX, T.8XXX.XX, ZXXX.XX,S.XXXX.XX, K0142.25

K012869 · Gimmi GmbH · Obstetrics & Gynecology
Mar 2002
Decision
196d
Days
Class 2
Risk

About This 510(k) Submission

K012869 is an FDA 510(k) clearance for the GIMMI ALPHA HYSTEROSCOPES & ACCESSORIES, MODELS E.8XXX.XX, T.8XXX.XX, ZXXX.XX,S.XXXX.XX, K0142.25, a Hysteroscope (and Accessories) (Class II — Special Controls, product code HIH), submitted by Gimmi GmbH (Amsterdam, Nh, NL). The FDA issued a Cleared decision on March 11, 2002, 196 days after receiving the submission on August 27, 2001. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.1690.

Submission Details

510(k) Number K012869 FDA.gov
FDA Decision Cleared SESE
Date Received August 27, 2001
Decision Date March 11, 2002
Days to Decision 196 days
Submission Type Abbreviated
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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