Cleared Traditional

K992027 - KONINCKX UTERINE MANIPULATOR, KECKSTEIN-SCHIFF UTERINE MANIPULATOR, CLERMONT UTERINE MANIPULATOR

K992027 is an FDA 510(k) clearance for KONINCKX UTERINE MANIPULATOR, manufactured by Karl Storz Endoscopy. The device is a Class 2 Obstetrics & Gynecology device with product code HIH cleared through the Traditional 510(k) pathway after a 85-day FDA review.

K992027 · Karl Storz Endoscopy · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K992027

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
Combination Product No
PCCP Authorized No
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.

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 Peers - HIH Hysteroscope (and Accessories)

All 146
Devices cleared under the same product code (HIH) and FDA review panel - the closest regulatory comparables to K992027.
GYNECARE VERSAPOINT G-VAP ELECTRODE
K992901 · Gynecare, Inc. · Jan 2000
GYRUS HYSTEROSCOPIC RESECTOSCOPE
K993749 · Gyrus Medical , Ltd. · Dec 1999
CONTINUOUS FLOW HYSTERO-RESECTOSCOPE, KNIFE ELECTRODE, SPIKE ELECTRODE, VAPORISATION ELECTRODE, COAGULATION ELECTRODE, C
K991563 · Henke Sass Wolf of America, Inc. · Oct 1999
MTP HAMOU ENDOMAT DISPOSABLE TUBING SETS
K990910 · Mtp Medical Technical Promotion GmbH · Jun 1999
MVM 7.5 FRENCH FLEXIBLE HYSTEROSCOPE
K990411 · Karl Storz Endoscopy · May 1999
VERSAPOINT ELECTROSURGERY SYSTEM (SCUBA)
K982738 · Gynecare, Inc. · Mar 1999