Cleared Traditional

K092278 - GYRUS ACMI INVISIO DIGITAL HYSTEROSCOPE

K092278 is the FDA 510(k) clearance for GYRUS ACMI INVISIO DIGITAL HYSTEROSCOPE by Gyrus Acmi, Inc.. It is a Class 2 Obstetrics & Gynecology device (product code HIH) cleared through the Traditional 510(k) pathway after a 63-day FDA review.

K092278 · Gyrus Acmi, Inc. · Obstetrics & Gynecology device
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Sep 2009
Decision
63d
Days
Class 2
Risk

K092278 is an FDA 510(k) clearance for the GYRUS ACMI INVISIO DIGITAL HYSTEROSCOPE, MODEL IDH-4. Classified as Hysteroscope (and Accessories) (product code HIH), Class II - Special Controls.

Submitted by Gyrus Acmi, Inc. (Southborough, US). The FDA issued a Cleared decision on September 29, 2009 after a review of 63 days - a notably fast clearance 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 Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Gyrus Acmi, Inc. devices

Submission Details

510(k) Number K092278 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 28, 2009
Decision Date September 29, 2009
Days to Decision 63 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
97d faster than avg
Panel avg: 160d · This submission: 63d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 100
Devices cleared under the same product code (HIH) and FDA review panel - the closest regulatory comparables to K092278.
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
IUR RECIPROCATING MORCELLATOR MODEL # 7210517
K041774 · Smith & Nephew, Inc. · Oct 2004
STRYKER UROLOGY AND GYNECOLOGY HARDWARE SYSTEM
K040390 · Stryker Endoscopy · May 2004
UNIVERSAL OPERATING HYSTERISCOPE SET BY SOLIMA-ZUPI, CONSISTING OF OPTIC, INNER AND OUTER SHEATHS, FORCEPS, MODEL 8753
K033113 · Richard Wolf Medical Instruments Corp. · Dec 2003