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Suction and Lavage Probe

by Medical Marketing, Inc.

510(k) K874614

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK874614 Date23 Jun 1988ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 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  • Withdrawn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
HET
Device Class
Class II
Regulation
21 CFR Part 884.1720
Advisory Committee
Obstetrics/Gynecology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 26 Sep 2026

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

A suction and lavage probe is a laparoscope, gynecologic (and accessories) device used in obstetrics/gynecology procedures. It is designed for suction and irrigation functions during laparoscopic surgery.

The device is supplied as a reusable instrument, cleared via FDA 510(k) under K874614 with product code HET and regulation number 884.1720. It is classified as a Class II device with traditional clearance, intended for use in clinical settings requiring laparoscopic access and fluid management.

Other devices from Medical Marketing, Inc.

Questions

AI-generated answers, 26 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 suction and lavage probe used for?

    The suction and lavage probe is a laparoscope, gynecologic (and accessories) device designed for suction and irrigation functions during laparoscopic surgery in obstetrics/gynecology procedures, enabling fluid management and tissue visualization.

  • Is the suction and lavage probe reusable or single-use?

    The device is supplied as a reusable instrument, meaning it is intended for multiple uses after proper cleaning, disinfection, and sterilization in accordance with the manufacturer's instructions and clinical protocols.

  • How was the suction and lavage probe cleared for market?

    The suction and lavage probe received FDA 510(k) clearance under K874614, demonstrating substantial equivalence to a legally marketed predicate device, and is classified as a Class II device under regulation number 884.1720 with product code HET.