Cleared Traditional

KONINCKX UTERINE MANIPULATOR, KECKSTEIN-SCHIFF UTERINE MANIPULATOR, CLERMONT UTERINE MANIPULATOR (K992027) - FDA 510(k) Clearance

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

K992027 · Karl Storz Endoscopy · Obstetrics & Gynecology device
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Sep 1999
Decision
85d
Days
Class 2
Risk

K992027 is an FDA 510(k) clearance for the KONINCKX UTERINE MANIPULATOR, KECKSTEIN-SCHIFF UTERINE MANIPULATOR, CLERMONT .... Classified as Hysteroscope (and Accessories) (product code HIH), Class II - Special Controls.

Submitted by Karl Storz Endoscopy (Culver City, US). The FDA issued a Cleared decision on September 9, 1999 after a review of 85 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 Karl Storz Endoscopy devices

Submission Details

510(k) Number K992027 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 16, 1999
Decision Date September 09, 1999
Days to Decision 85 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
75d faster than avg
Panel avg: 160d · This submission: 85d
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 73
Devices cleared under the same product code (HIH) and FDA review panel - the closest regulatory comparables to K992027.
SMITH & NEPHEW OPERATIVE HYSTEROSCOPE, MODEL 7209208
K013870 · Smith & Nephew, Inc. · Jan 2002
KSEA MONOPOLAR VAPORIZATION ELECTRODES
K001740 · KARL STORZ Endoscopy-America, Inc. · Aug 2000
VERSAPOINT ELECTROSURGERY SYSTEM (SCUBA)
K994418 · Ethicon, Inc. · Jan 2000
KSEA HF-SNARE
K983901 · KARL STORZ Endoscopy-America, Inc. · Feb 1999
KSEA MONOPOLAR VAPORIZATION ELECTRODES
K983569 · KARL STORZ Endoscopy-America, Inc. · Jan 1999
KSEA SEMI-RIGID HYSTEROSCOPE AND ACCESSORIES
K971518 · KARL STORZ Endoscopy-America, Inc. · Jul 1997