Cleared Traditional

K991563 - CONTINUOUS FLOW HYSTERO-RESECTOSCOPE

K991563 is an FDA 510(k) clearance for CONTINUOUS FLOW HYSTERO-RESECTOSCOPE, manufactured by Henke Sass Wolf of America, Inc.. The device is a Class 2 Obstetrics & Gynecology device with product code HIH cleared through the Traditional 510(k) pathway after a 161-day FDA review.

K991563 · Henke Sass Wolf of America, Inc. · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1999
Decision
161d
Days
Class 2
Risk

K991563 is an FDA 510(k) clearance for the CONTINUOUS FLOW HYSTERO-RESECTOSCOPE, KNIFE ELECTRODE, SPIKE ELECTRODE, VAPOR.... Classified as Hysteroscope (and Accessories) (product code HIH), Class II - Special Controls.

Submitted by Henke Sass Wolf of America, Inc. (Duxbury, US). The FDA issued a Cleared decision on October 13, 1999 after a review of 161 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Obstetrics & Gynecology review framework, consistent with the majority of Class II 510(k) submissions.

View all Henke Sass Wolf of America, Inc. devices

FDA 510(k) Submission Details - K991563

510(k) Number K991563 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 05, 1999
Decision Date October 13, 1999
Days to Decision 161 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
1d slower than avg
Panel avg: 160d · This submission: 161d
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 110
Devices cleared under the same product code (HIH) and FDA review panel - the closest regulatory comparables to K991563.
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