Cleared Abbreviated

K092421 - ALPHAHYSTEROSCOPE

K092421 is the FDA 510(k) clearance for ALPHAHYSTEROSCOPE by Gimmi GmbH. It is a Class 2 Obstetrics & Gynecology device (product code HIH) cleared through the Abbreviated 510(k) pathway after a 189-day FDA review.

K092421 · Gimmi GmbH · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2010
Decision
189d
Days
Class 2
Risk

K092421 is an FDA 510(k) clearance for the ALPHAHYSTEROSCOPE, FIBEROPTIC, OPERATIVE AND DIAGNOSTIC. Classified as Hysteroscope (and Accessories) (product code HIH), Class II - Special Controls.

Submitted by Gimmi GmbH (Saint Paul, US). The FDA issued a Cleared decision on February 12, 2010 after a review of 189 days - an extended review cycle.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.1690 - the FDA obstetrics and gynecology device framework. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Gimmi GmbH devices

Submission Details

510(k) Number K092421 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 07, 2009
Decision Date February 12, 2010
Days to Decision 189 days
Submission Type Abbreviated
Review Panel Obstetrics & Gynecology (OB)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
29d slower than avg
Panel avg: 160d · This submission: 189d
Pathway characteristics
Standards-based clearance path.

Device Classification

Product Code HIH Hysteroscope (and Accessories)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 884.1690
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Obstetrics & Gynecology devices follow this clearance model.

Regulatory Peers - HIH Hysteroscope (and Accessories)

All 107
Devices cleared under the same product code (HIH) and FDA review panel - the closest regulatory comparables to K092421.
TRUCLEAR OPERATIVE HYSTEROSCOPE
K112134 · Smith & Nephew, Inc. · Nov 2011
TRUCLEAR MORCELLATOR SYSTEM
K110038 · Smith & Nephew, Inc. · Mar 2011
TRUCLEAR INCISOR PLUS BLADE 2.9
K103389 · Smith & Nephew, Inc. · Mar 2011
GYRUS ACMI INVISIO DIGITAL HYSTEROSCOPE, MODEL IDH-4
K092278 · Gyrus Acmi, Inc. · Sep 2009
IUR RECIPROCATING MORCELLATOR MODEL # 7210517
K041774 · Smith & Nephew, Inc. · Oct 2004
STRYKER UROLOGY AND GYNECOLOGY HARDWARE SYSTEM
K040390 · Stryker Endoscopy · May 2004