Cleared Traditional

TROCARS, TROCAR SLEEVES AND REDUCTION SLEEVES (K942389) - FDA 510(k) Clearance

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

K942389 · Hogan & Hartson · Obstetrics & Gynecology device
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Optimized for regulatory review, auditing and printing
Feb 1996
Decision
639d
Days
Class 2
Risk

K942389 is an FDA 510(k) clearance for the TROCARS, TROCAR SLEEVES AND REDUCTION SLEEVES. Classified as Laparoscope, Gynecologic (and Accessories) (product code HET), Class II - Special Controls.

Submitted by Hogan & Hartson (Washington, US). The FDA issued a Cleared decision on February 16, 1996 after a review of 639 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 Hogan & Hartson devices

Submission Details

510(k) Number K942389 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 18, 1994
Decision Date February 16, 1996
Days to Decision 639 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
479d slower than avg
Panel avg: 160d · This submission: 639d
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 96
Devices cleared under the same product code (HET) and FDA review panel - the closest regulatory comparables to K942389.
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
OLYMPUS 3D SURGICAL ENDOSCOPY SYSTEM
K943305 · Olympus America, Inc. · Nov 1995
KARL STORZ TAKE-APART BIOPOLAR FORCEPS
K953809 · KARL STORZ Endoscopy-America, Inc. · Nov 1995
OLYMPUS SUPERVIEW LAPAROSCOPE FOR OB/GYN
K942838 · Olympus America, Inc. · Oct 1995