Cleared Traditional

K943305 - OLYMPUS 3D SURGICAL ENDOSCOPY SYSTEM

K943305 is the FDA 510(k) clearance for OLYMPUS 3D SURGICAL ENDOSCOPY SYSTEM by Olympus America, Inc.. It is a Class 2 Obstetrics & Gynecology device (product code HET) cleared through the Traditional 510(k) pathway after a 497-day FDA review.

K943305 · Olympus America, Inc. · Obstetrics & Gynecology device
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Optimized for regulatory review, auditing and printing
Nov 1995
Decision
497d
Days
Class 2
Risk

K943305 is an FDA 510(k) clearance for the OLYMPUS 3D SURGICAL ENDOSCOPY SYSTEM. Classified as Laparoscope, Gynecologic (and Accessories) (product code HET), Class II - Special Controls.

Submitted by Olympus America, Inc. (Lake Success, US). The FDA issued a Cleared decision on November 17, 1995 after a review of 497 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.1720 - 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Obstetrics & Gynecology submissions.

View all Olympus America, Inc. devices

Submission Details

510(k) Number K943305 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 08, 1994
Decision Date November 17, 1995
Days to Decision 497 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
337d slower than avg
Panel avg: 160d · This submission: 497d
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 152
Devices cleared under the same product code (HET) and FDA review panel - the closest regulatory comparables to K943305.
KARL STORZ SEMI-RIGID MICRO-ENDOSCOPES & ACCESSORIES FOR ENDOSCCOPIC GYNECOLOGICAL SURGICAL PROCEDURES
K951343 · KARL STORZ Endoscopy-America, Inc. · Apr 1996
OES LAPARO-THORACO VIDEOSCOPE TYPE V
K955403 · Olympus America, Inc. · Mar 1996
OES LAPARO-THORACO VIDEOSCOPE (RIGID)
K955456 · Olympus America, Inc. · Feb 1996
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K953809 · KARL STORZ Endoscopy-America, Inc. · Nov 1995
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K942838 · Olympus America, Inc. · Oct 1995
KARL STORZ PRESSURE CUFF FOR USE WITH THE KSEA HYDROMAT PUMP
K951105 · KARL STORZ Endoscopy-America, Inc. · Oct 1995