Cleared Traditional

OES LAPARO-THORACO VIDEOSCOPE TYPE V (K955403) - FDA 510(k) Clearance

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

K955403 · Olympus America, Inc. · Obstetrics & Gynecology device
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Optimized for regulatory review, auditing and printing
Mar 1996
Decision
105d
Days
Class 2
Risk

K955403 is an FDA 510(k) clearance for the OES LAPARO-THORACO VIDEOSCOPE TYPE V. Classified as Laparoscope, Gynecologic (and Accessories) (product code HET), Class II - Special Controls.

Submitted by Olympus America, Inc. (Melville, US). The FDA issued a Cleared decision on March 11, 1996 after a review of 105 days - within the typical 510(k) review window.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.1720 - 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 Olympus America, Inc. devices

Submission Details

510(k) Number K955403 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 27, 1995
Decision Date March 11, 1996
Days to Decision 105 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
55d faster than avg
Panel avg: 160d · This submission: 105d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code HET Laparoscope, Gynecologic (and Accessories)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 884.1720
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 - HET Laparoscope, Gynecologic (and Accessories)

All 77
Devices cleared under the same product code (HET) and FDA review panel - the closest regulatory comparables to K955403.
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K950335 · KARL STORZ Endoscopy-America, Inc. · May 1996
KARL STORZ SEMI-RIGID MICRO-ENDOSCOPES & ACCESSORIES FOR ENDOSCCOPIC GYNECOLOGICAL SURGICAL PROCEDURES
K951343 · KARL STORZ Endoscopy-America, Inc. · Apr 1996
KARL STORZ TAKE-APART BIOPOLAR FORCEPS
K953809 · KARL STORZ Endoscopy-America, Inc. · Nov 1995
KARL STORZ PRESSURE CUFF FOR USE WITH THE KSEA HYDROMAT PUMP
K951105 · KARL STORZ Endoscopy-America, Inc. · Oct 1995
KSEA MODEL 203200 20 UNIMAT
K953190 · KARL STORZ Endoscopy-America, Inc. · Oct 1995