Cleared Traditional

OPTUS HYSTEROSCOPES AND CONTACT HYSTEROSCOPES (K945265) - FDA 510(k) Clearance

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

K945265 · Optus, Inc. · Obstetrics & Gynecology device
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Sep 1995
Decision
319d
Days
Class 2
Risk

K945265 is an FDA 510(k) clearance for the OPTUS HYSTEROSCOPES AND CONTACT HYSTEROSCOPES. Classified as Hysteroscope (and Accessories) (product code HIH), Class II - Special Controls.

Submitted by Optus, Inc. (Denver, US). The FDA issued a Cleared decision on September 12, 1995 after a review of 319 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Optus, Inc. devices

Submission Details

510(k) Number K945265 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 28, 1994
Decision Date September 12, 1995
Days to Decision 319 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
159d slower than avg
Panel avg: 160d · This submission: 319d
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 86
Devices cleared under the same product code (HIH) and FDA review panel - the closest regulatory comparables to K945265.
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
A4722 OLYMPUS OPTICAL OBTURATOR
K950055 · Olympus America, Inc. · Feb 1995
OLYMPUS 5FR SEMI-RIGID SCISSORS FOR OB/GYN
K950036 · Olympus America, Inc. · Feb 1995
HF RESECTION ELECTRODE, LOOP W/RUNNER HYSTER/ACCES
K931764 · Olympus Corp. · Jun 1994