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KSEA Thermocoagulator (Model 265100 20)

by Karl Storz Endoscopy-America, Inc.

510(k) K963852

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 6 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 6 Oct 2026. What this means

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK963852 Date10 Dec 1996ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 6 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
HGI
Device Class
Class II
Regulation
21 CFR Part 884.4120
Advisory Committee
Obstetrics/Gynecology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 22 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The KSEA Thermocoagulator (Model 265100 20) is a gynecologic electrocautery generator and accessory device, as defined by its device name and classification under regulation number 884.4120. It is a Class II medical device that received FDA 510(k) clearance (K963852) on December 10, 1996, and was found substantially equivalent to a predicate device.

The device is supplied by Karl Storz Endoscopy-America, Inc. located at 600 Corporate Pointe, Culver City, CA 90230. It is intended for use in obstetrics and gynecology applications, as indicated by the advisory committee designation OB and the medical specialty description Obstetrics/Gynecology. No information regarding sterility, single-use or reusable status, MRI safety, sizes, or storage conditions is provided in the data.

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Questions

AI-generated answers, 22 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the KSEA Thermocoagulator Model 265100 20 used for?

    The KSEA Thermocoagulator (Model 265100 20) is a gynecologic electrocautery generator and accessory device intended for use in obstetrics and gynecology applications, as indicated by its device name, classification under regulation number 884.4120, and advisory committee designation OB.

  • How is the KSEA Thermocoagulator Model 265100 20 supplied and by whom?

    The device is supplied by Karl Storz Endoscopy-America, Inc., located at 600 Corporate Pointe, Culver City, CA 90230, as the manufacturer and applicant listed in the FDA 510(k) submission for this specific model.

  • What regulatory pathway was used for the KSEA Thermocoagulator Model 265100 20?

    The KSEA Thermocoagulator (Model 265100 20) received FDA 510(k) clearance (K963852) on December 10, 1996, through a traditional 510(k) submission, and was found substantially equivalent to a predicate device under regulation number 884.4120.