Cleared Traditional

K895857 - CONTINUOUS IRRIGATION RESECTOSCOPE SYST/GYNECOLOGY

K895857 is an FDA 510(k) clearance for CONTINUOUS IRRIGATION RESECTOSCOPE SYST..., manufactured by Richard Wolf Medical Instruments Corp.. The device is a Class 2 Obstetrics & Gynecology device with product code HIH cleared through the Traditional 510(k) pathway after a 262-day FDA review.

K895857 · Richard Wolf Medical Instruments Corp. · Obstetrics & Gynecology device
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Optimized for regulatory review, auditing and printing
Jun 1990
Decision
262d
Days
Class 2
Risk

K895857 is an FDA 510(k) clearance for the CONTINUOUS IRRIGATION RESECTOSCOPE SYST/GYNECOLOGY. Classified as Hysteroscope (and Accessories) (product code HIH), Class II - Special Controls.

Submitted by Richard Wolf Medical Instruments Corp. (Rosemont, US). The FDA issued a Cleared decision on June 22, 1990 after a review of 262 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 Richard Wolf Medical Instruments Corp. devices

FDA 510(k) Submission Details - K895857

510(k) Number K895857 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 03, 1989
Decision Date June 22, 1990
Days to Decision 262 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
102d slower than avg
Panel avg: 160d · This submission: 262d
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 143
Devices cleared under the same product code (HIH) and FDA review panel - the closest regulatory comparables to K895857.
RESECTOSCOPE SHEATH
K931994 · Olympus Corp. · Feb 1994
RG27-SERIES RESECTOSCOPE AND ACCESSORIES
K914108 · CooperSurgical, Inc. · Mar 1992
HYSTEROSCOPY SHEATH SET
K903146 · Cook, Inc. · Oct 1990
OLYMPUS HYSTERORESECTOSCOPE
K897003 · Olympus Corp. · Mar 1990
HYSTEROSCOPE
K896917 · Cabot Medical Corp. · Mar 1990
MODELS 27040 & 27050 CONTI. FLOW RESECTOSCOPES
K882270 · KARL STORZ Endoscopy-America, Inc. · Oct 1989