Cleared Traditional

K963852 - KSEA THERMOCOAGULATOR (MODEL 265100 20)

K963852 is an FDA 510(k) clearance for KSEA THERMOCOAGULATOR (MODEL 265100 20), manufactured by KARL STORZ Endoscopy-America, Inc.. The device is a Class 2 Obstetrics & Gynecology device with product code HGI cleared through the Traditional 510(k) pathway after a 76-day FDA review.

K963852 · KARL STORZ Endoscopy-America, Inc. · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 1996
Decision
76d
Days
Class 2
Risk

K963852 is an FDA 510(k) clearance for the KSEA THERMOCOAGULATOR (MODEL 265100 20). Classified as Electrocautery, Gynecologic (and Accessories) (product code HGI), Class II - Special Controls.

Submitted by KARL STORZ Endoscopy-America, Inc. (Culver City, US). The FDA issued a Cleared decision on December 10, 1996 after a review of 76 days - a notably fast clearance cycle.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.4120 - 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 - K963852

510(k) Number K963852 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 25, 1996
Decision Date December 10, 1996
Days to Decision 76 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
84d faster than avg
Panel avg: 160d · This submission: 76d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HGI Device Classification - Class 2, Special Controls

Product Code HGI Electrocautery, Gynecologic (and Accessories)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 884.4120
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 - HGI Electrocautery, Gynecologic (and Accessories)

All 33
Devices cleared under the same product code (HGI) and FDA review panel - the closest regulatory comparables to K963852.
TBD
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WALLACH INTEGRATION UNIT
K963348 · Wallach Surgical Devices, Inc. · Mar 1997
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K955756 · KARL STORZ Endoscopy-America, Inc. · Nov 1996
LWEET CONE BIOPSY INSTRUMENT
K961460 · Apple Medical Corp. · Nov 1996
LOOP/SQUARE ELECTRODE
K952030 · E & M Engineering, Inc. · Jul 1996