Cleared Traditional

K880314 - HYSTEROSCOPE AUTONOM 4992

K880314 is an FDA 510(k) clearance for HYSTEROSCOPE AUTONOM 4992, 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 212-day FDA review.

K880314 · Richard Wolf Medical Instruments Corp. · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1988
Decision
212d
Days
Class 2
Risk

K880314 is an FDA 510(k) clearance for the HYSTEROSCOPE AUTONOM 4992. 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 August 25, 1988 after a review of 212 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 - K880314

510(k) Number K880314 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 26, 1988
Decision Date August 25, 1988
Days to Decision 212 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
52d slower than avg
Panel avg: 160d · This submission: 212d
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 K880314.
HYSTEROSCOPE
K896917 · Cabot Medical Corp. · Mar 1990
MODELS 27040 & 27050 CONTI. FLOW RESECTOSCOPES
K882270 · KARL STORZ Endoscopy-America, Inc. · Oct 1989
OLYMPUS HYF-P FLEXIBLE HYSTEROFIBERSCOPE
K891451 · Olympus Corp. · Oct 1989
SCOPE LIGHT
K841825 · Zinnanti Surgical Instruments, Inc. · Jun 1984
CONTACT-MICRO COLPOHYSTEROSCOPE
K810569 · KARL STORZ Endoscopy-America, Inc. · Jul 1981