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HPU Heat Probe Automated Electrocautery System

by Olympus Corp. 510(k)

Active United States

510(k) K851096

Overview

The HPU Heat Probe Automated Electrocautery System is a Unit, Electrosurgical, Endoscopic (With Or Without Accessories) device. It is classified under product code KNS and is substantially equivalent to a predicate device as determined by FDA 510(k) clearance.

The system was cleared by the FDA through traditional 510(k) submission K851096 on May 22, 1985. It is manufactured by Olympus Corp. and is intended for use in gastroenterology and urology specialties. The device operates as a Class II medical device subject to special controls under regulation number 876.4300.

AI-generated from registry data, 25 Sep 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK851096 Date22 May 1985ClearedStatusActive

Coverage

1 jurisdiction

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

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

510(k)

510(k) Number
FDA Product Code
KNS
Device Class
Class II
Regulation
21 CFR Part 876.4300
Advisory Committee
Gastroenterology, Urology
FDA Decision
SESE Substantially Equivalent

Other devices from Olympus Corp.

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Questions

  • What is the HPU Heat Probe Automated Electrocautery System used for?

    The HPU Heat Probe Automated Electrocautery System is intended for use in gastroenterology and urology specialties as a Unit, Electrosurgical, Endoscopic (With Or Without Accessories) device, based on its FDA 510(k) clearance and product code KNS classification.

  • How is the HPU Heat Probe Automated Electrocautery System supplied or accessed?

    The system is manufactured by Olympus Corp. and was cleared via traditional 510(k) submission K851096 on May 22, 1985, indicating it is a commercially available device distributed through standard medical device channels for endoscopic electrosurgical procedures.

  • Is the HPU Heat Probe Automated Electrocautery System reusable or single-use?

    The device data does not specify whether the HPU Heat Probe Automated Electrocautery System is reusable or single-use; therefore, no determination can be made about its reusability based solely on the provided information.

  • What regulatory pathway was used for the HPU Heat Probe Automated Electrocautery System?

    The HPU Heat Probe Automated Electrocautery System received FDA clearance through a traditional 510(k) submission (K851096) on May 22, 1985, and is classified as a Class II medical device under regulation number 876.4300 with product code KNS.

  • What are the key identifiers for the HPU Heat Probe Automated Electrocautery System?

    The device is identified by the name HPU Heat Probe Automated Electrocautery System, manufacturer Olympus Corp., FDA 510(k) number K851096, product code KNS, and regulation number 876.4300, which together distinguish it from other similar devices in the manufacturer's portfolio.