Cleared Traditional

Schoelly Cystoscopes/Hysteroscopes and Accessories (K150158) - FDA 510(k) Clearance

Class II Obstetrics & Gynecology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K150158 · Schoelly Fiberoptic GmbH · Obstetrics & Gynecology device
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Mar 2015
Decision
45d
Days
Class 2
Risk

K150158 is an FDA 510(k) clearance for the Schoelly Cystoscopes/Hysteroscopes and Accessories. Classified as Hysteroscope (and Accessories) (product code HIH), Class II - Special Controls.

Submitted by Schoelly Fiberoptic GmbH (Denzlingen, DE). The FDA issued a Cleared decision on March 9, 2015 after a review of 45 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 Schoelly Fiberoptic GmbH devices

Submission Details

510(k) Number K150158 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 23, 2015
Decision Date March 09, 2015
Days to Decision 45 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Regulatory Context
Review time vs. panel average
115d faster than avg
Panel avg: 160d · This submission: 45d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

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 94
Devices cleared under the same product code (HIH) and FDA review panel - the closest regulatory comparables to K150158.
Smith & Nephew TRUCLEAR ULTRA Mini Tissue Removal Device
K161763 · Smith & Nephew, Inc. · Nov 2016
Myosure Hysteroscopic Tissue Removal System and Myosure Tissue Removal Devices
K152723 · Hologic, Inc. · Nov 2015
TRUCLEAR Operative Hysteroscope 5C and Sheath 5C
K152143 · Smith & Nephew, Inc. · Sep 2015
MYOSURE HYSTEROSCOPIC TISSUE REMOVAL SYSTEM
K142029 · Hologic, Inc. · Nov 2014
TRUCLEAR MORCELLATION SYSTEM AND TRUCLEAR MORCELLATORS
K132015 · Smith & Nephew, Inc. · Dec 2013
MYOSURE TISSUE REMOVAL DEVICE (1 PACK AND 3 PACK)
K131581 · Hologic, Inc. · Aug 2013