Cleared Special

K993749 - GYRUS HYSTEROSCOPIC RESECTOSCOPE

K993749 is an FDA 510(k) clearance for GYRUS HYSTEROSCOPIC RESECTOSCOPE, manufactured by Gyrus Medical , Ltd.. The device is a Class 2 Obstetrics & Gynecology device with product code HIH cleared through the Special 510(k) pathway after a 28-day FDA review.

K993749 · Gyrus Medical , Ltd. · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 1999
Decision
28d
Days
Class 2
Risk

K993749 is an FDA 510(k) clearance for the GYRUS HYSTEROSCOPIC RESECTOSCOPE. Classified as Hysteroscope (and Accessories) (product code HIH), Class II - Special Controls.

Submitted by Gyrus Medical , Ltd. (Cardiff, Wales, GB). The FDA issued a Cleared decision on December 3, 1999 after a review of 28 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Gyrus Medical , Ltd. devices

FDA 510(k) Submission Details - K993749

510(k) Number K993749 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 05, 1999
Decision Date December 03, 1999
Days to Decision 28 days
Submission Type Special
Review Panel Obstetrics & Gynecology (OB)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
132d faster than avg
Panel avg: 160d · This submission: 28d
Pathway characteristics
Modification to existing cleared device.

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 110
Devices cleared under the same product code (HIH) and FDA review panel - the closest regulatory comparables to K993749.
KSEA MONOPOLAR VAPORIZATION ELECTRODES
K001740 · KARL STORZ Endoscopy-America, Inc. · Aug 2000
HYSTEROSCOPE OPERATING SHEATH AND INSERT, MODEL 8988.031/.041/.231/.241
K000673 · Richard Wolf Medical Instruments Corp. · May 2000
VERSAPOINT ELECTROSURGERY SYSTEM (SCUBA)
K994418 · Ethicon, Inc. · Jan 2000
KONINCKX UTERINE MANIPULATOR, KECKSTEIN-SCHIFF UTERINE MANIPULATOR, CLERMONT UTERINE MANIPULATOR
K992027 · Karl Storz Endoscopy · Sep 1999
MVM 7.5 FRENCH FLEXIBLE HYSTEROSCOPE
K990411 · Karl Storz Endoscopy · May 1999
KSEA HF-SNARE
K983901 · KARL STORZ Endoscopy-America, Inc. · Feb 1999