Cleared Traditional

K955456 - OES LAPARO-THORACO VIDEOSCOPE (RIGID)

K955456 is an FDA 510(k) clearance for OES LAPARO-THORACO VIDEOSCOPE (RIGID), manufactured by Olympus America, Inc.. The device is a Class 2 Obstetrics & Gynecology device with product code HET cleared through the Traditional 510(k) pathway after a 85-day FDA review.

K955456 · Olympus America, Inc. · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1996
Decision
85d
Days
Class 2
Risk

K955456 is an FDA 510(k) clearance for the OES LAPARO-THORACO VIDEOSCOPE (RIGID). 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 February 22, 1996 after a review of 85 days - a notably fast clearance cycle.

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: 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

FDA 510(k) Submission Details - K955456

510(k) Number K955456 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 29, 1995
Decision Date February 22, 1996
Days to Decision 85 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
75d faster than avg
Panel avg: 160d · This submission: 85d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HET Device Classification - Class 2, Special Controls

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 227
Devices cleared under the same product code (HET) and FDA review panel - the closest regulatory comparables to K955456.
CORING MORCELLATOR
K960262 · Cook Urological, Inc. · Apr 1996
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
TROCARS, TROCAR SLEEVES AND REDUCTION SLEEVES
K942389 · Hogan & Hartson · Feb 1996
R-MED ABDOMINAL WALL ELEVATOR
K953360 · R-Med, Inc. · Jan 1996
OLYMPUS 3D SURGICAL ENDOSCOPY SYSTEM
K943305 · Olympus America, Inc. · Nov 1995