Cleared Traditional

K950055 - A4722 OLYMPUS OPTICAL OBTURATOR

K950055 is the FDA 510(k) clearance for A4722 OLYMPUS OPTICAL OBTURATOR by Olympus America, Inc.. It is a Class 2 Obstetrics & Gynecology device (product code HIH) cleared through the Traditional 510(k) pathway after a 46-day FDA review.

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
Combination Product No
PCCP Authorized No
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 109
Devices cleared under the same product code (HIH) and FDA review panel - the closest regulatory comparables to K950055.
KARL STORZ FLEXIBLE HYSTERSCOPE
K952779 · KARL STORZ Endoscopy-America, Inc. · Oct 1995
HAND EXTRACTOR HECTOR
K953109 · Karl Storz Endoscopy · Aug 1995
FUJINON VIDEO LAPORASCOPE
K933544 · Fujinon, Inc. · Apr 1995
OLYMPUS 5FR SEMI-RIGID SCISSORS FOR OB/GYN
K950036 · Olympus America, Inc. · Feb 1995
CONTINUOUS FLOW HYSTERO-RESECTOSCOPE
K922420 · Linvatec Corp. · Jun 1994
HF RESECTION ELECTRODE, LOOP W/RUNNER HYSTER/ACCES
K931764 · Olympus Corp. · Jun 1994