Cleared Traditional

K000673 - HYSTEROSCOPE OPERATING SHEATH AND INSERT

K000673 is the FDA 510(k) clearance for HYSTEROSCOPE OPERATING SHEATH AND INSERT by Richard Wolf Medical Instruments Corp.. It is a Class 2 Obstetrics & Gynecology device (product code HIH) cleared through the Traditional 510(k) pathway after a 88-day FDA review.

K000673 · Richard Wolf Medical Instruments Corp. · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2000
Decision
88d
Days
Class 2
Risk

K000673 is an FDA 510(k) clearance for the HYSTEROSCOPE OPERATING SHEATH AND INSERT, MODEL 8988.031/.041/.231/.241. Classified as Hysteroscope (and Accessories) (product code HIH), Class II - Special Controls.

Submitted by Richard Wolf Medical Instruments Corp. (Vernon Hills, US). The FDA issued a Cleared decision on May 26, 2000 after a review of 88 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 Richard Wolf Medical Instruments Corp. devices

Submission Details

510(k) Number K000673 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 28, 2000
Decision Date May 26, 2000
Days to Decision 88 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
72d faster than avg
Panel avg: 160d · This submission: 88d
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 106
Devices cleared under the same product code (HIH) and FDA review panel - the closest regulatory comparables to K000673.
SMITH & NEPHEW IUR MORCELLATION SYSTEM
K031787 · Smith & Nephew, Inc. · Dec 2003
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
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