Cleared Traditional

K964436 - WESTERN SURGICAL REUSABLE LAPAROSCOPIC TROCAR SYSTEM

K964436 is an FDA 510(k) clearance for WESTERN SURGICAL REUSABLE LAPAROSCOPIC ..., manufactured by Western Surgical Instrument Co.. The device is a Class 2 Obstetrics & Gynecology device with product code HET cleared through the Traditional 510(k) pathway after a 86-day FDA review.

K964436 · Western Surgical Instrument Co. · Obstetrics & Gynecology device
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Jan 1997
Decision
86d
Days
Class 2
Risk

K964436 is an FDA 510(k) clearance for the WESTERN SURGICAL REUSABLE LAPAROSCOPIC TROCAR SYSTEM. Classified as Laparoscope, Gynecologic (and Accessories) (product code HET), Class II - Special Controls.

Submitted by Western Surgical Instrument Co. (San Antonio, US). The FDA issued a Cleared decision on January 30, 1997 after a review of 86 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 Western Surgical Instrument Co. devices

FDA 510(k) Submission Details - K964436

510(k) Number K964436 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 05, 1996
Decision Date January 30, 1997
Days to Decision 86 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
74d faster than avg
Panel avg: 160d · This submission: 86d
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 217
Devices cleared under the same product code (HET) and FDA review panel - the closest regulatory comparables to K964436.
INTERCEPTRE LAPAROSCOPIC INSTRUMENTS
K970151 · Smith & Nephew, Inc. · Mar 1997
IMAGYN MICROLAP AND MICRO LAP-GOLD LAPAROSCOPES
K965055 · Imagyn Medical, Inc. · Mar 1997
RIWO CUT-MORCELLATOR EXISTING OF KNIFE/CUTTING SLEEVE/PROTECTION SLEEVE/CLAW GRASPING FORCEPS
K970105 · Richard Wolf Medical Instruments Corp. · Mar 1997
KSEA PUNCTURE CANNULA
K964379 · KARL STORZ Endoscopy-America, Inc. · Jan 1997
SECONDARY TROCAR AND SLEEVE WITH INSUFFLATION PORT
K964450 · Pilling Weck Group · Jan 1997
KSEA UNIMAT PLUS
K963960 · KARL STORZ Endoscopy-America, Inc. · Dec 1996