Cleared Traditional

K150158 - Schoelly Cystoscopes/Hysteroscopes and Accessories

K150158 is an FDA 510(k) clearance for Schoelly Cystoscopes/Hysteroscopes and ..., manufactured by Schoelly Fiberoptic GmbH. The device is a Class 2 Obstetrics & Gynecology device with product code HIH cleared through the Traditional 510(k) pathway after a 45-day FDA review.

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

FDA 510(k) Submission Details - K150158

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
116d faster than avg
Panel avg: 161d · This submission: 45d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

HIH Device Classification - Class 2, Special Controls

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 Consultant

Regulatory Technology Services, LLC
MARK JOB

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - HIH Hysteroscope (and Accessories)

All 158
Devices cleared under the same product code (HIH) and FDA review panel - the closest regulatory comparables to K150158.
MAKO Device
K151275 · Nvision Medical · Nov 2015
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
AED HYSTEROSCOPE AND ACCESSORIES
K141515 · National Advanced Endoscopy Devices, Inc. · Jan 2015
MYOSURE HYSTEROSCOPIC TISSUE REMOVAL SYSTEM
K142029 · Hologic, Inc. · Nov 2014
U-SCOPE 8000 SYSTEM WITH HSC+EMB CANNULA
K132384 · Endosec Corporation · Jul 2014

FDA 510(k) Resources - Obstetrics & Gynecology

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.