Cleared Traditional

K895857 - CONTINUOUS IRRIGATION RESECTOSCOPE SYST...

K895857 is the FDA 510(k) clearance for CONTINUOUS IRRIGATION RESECTOSCOPE SYST... 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 262-day FDA review.

K895857 · Richard Wolf Medical Instruments Corp. · Obstetrics & Gynecology device
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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

Submission Details

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.

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 107
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