Cleared Traditional

A4722 OLYMPUS OPTICAL OBTURATOR (K950055) - FDA 510(k) Clearance

Class II Obstetrics & Gynecology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K950055 · Olympus America, Inc. · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1995
Decision
46d
Days
Class 2
Risk

K950055 is an FDA 510(k) clearance for the A4722 OLYMPUS OPTICAL OBTURATOR. Classified as Hysteroscope (and Accessories) (product code HIH), Class II - Special Controls.

Submitted by Olympus America, Inc. (Lake Success, US). The FDA issued a Cleared decision on February 21, 1995 after a review of 46 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 Olympus America, Inc. devices

Submission Details

510(k) Number K950055 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 06, 1995
Decision Date February 21, 1995
Days to Decision 46 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
114d faster than avg
Panel avg: 160d · This submission: 46d
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 73
Devices cleared under the same product code (HIH) and FDA review panel - the closest regulatory comparables to K950055.
KARL STORZ 10.5 FR. FLEXIBLE HYSTEROSCOPE
K961605 · KARL STORZ Endoscopy-America, Inc. · Nov 1996
KARL STORZ FIXED MAGNIFICATION TELESCOPE/KS VARIABLE MAGNIFICATION TELESCOPE
K935716 · KARL STORZ Endoscopy-America, Inc. · Nov 1995
KARL STORZ FLEXIBLE HYSTERSCOPE
K952779 · KARL STORZ Endoscopy-America, Inc. · Oct 1995
HYSTEROSCOPY SHEATH SET
K903146 · Cook, Inc. · Oct 1990
MODELS 27040 & 27050 CONTI. FLOW RESECTOSCOPES
K882270 · KARL STORZ Endoscopy-America, Inc. · Oct 1989
CONTACT-MICRO COLPOHYSTEROSCOPE
K810569 · KARL STORZ Endoscopy-America, Inc. · Jul 1981