Cleared Traditional

K964379 - KSEA PUNCTURE CANNULA

K964379 is an FDA 510(k) clearance for KSEA PUNCTURE CANNULA, manufactured by KARL STORZ Endoscopy-America, Inc.. 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.

K964379 · KARL STORZ Endoscopy-America, Inc. · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 1997
Decision
86d
Days
Class 2
Risk

K964379 is an FDA 510(k) clearance for the KSEA PUNCTURE CANNULA. Classified as Laparoscope, Gynecologic (and Accessories) (product code HET), Class II - Special Controls.

Submitted by KARL STORZ Endoscopy-America, Inc. (Culver City, US). The FDA issued a Cleared decision on January 29, 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 KARL STORZ Endoscopy-America, Inc. devices

FDA 510(k) Submission Details - K964379

510(k) Number K964379 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 04, 1996
Decision Date January 29, 1997
Days to Decision 86 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
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 225
Devices cleared under the same product code (HET) and FDA review panel - the closest regulatory comparables to K964379.
S*E*M*M* SET FOR MOTO DRIVE WISAP #7689 SSM (MODIFICATION)
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K962246 · Health Care International Assoc. · Feb 1997
WESTERN SURGICAL REUSABLE LAPAROSCOPIC TROCAR SYSTEM
K964436 · Western Surgical Instrument Co. · Jan 1997
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K963872 · Gynecare Innovation Center · Jan 1997
SECONDARY TROCAR AND SLEEVE WITH INSUFFLATION PORT
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KSEA UNIMAT PLUS
K963960 · KARL STORZ Endoscopy-America, Inc. · Dec 1996