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Nezhat/Dorsey Hydro Dissection Pump and Accessories

by American Surgical Instruments Corp.

510(k) K913944

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)SESK Substantially Equivalent — Kit · Traditional NumberK913944 Date9 Mar 1992ClearedStatusActive

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  • Withdrawn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)

Full name
Nezhat/Dorsey Hydro Dissection Pump & Accessories
510(k) Number
FDA Product Code
HET
Device Class
Class II
Regulation
21 CFR Part 884.1720
Advisory Committee
Obstetrics/Gynecology
FDA Decision
SESK Substantially Equivalent — Kit

Overview

AI-generated summary, 1 Oct 2026

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

The Nezhat/Dorsey Hydro Dissection Pump and Accessories is a hydro-dissection system designed for gynecologic and laparoscopic surgical procedures. It facilitates tissue separation and fluid management during minimally invasive surgeries, particularly in obstetrics and gynecology, by delivering pressurized irrigation fluids to dissect delicate anatomical structures.

This device is intended for single-use in controlled surgical environments, such as operating rooms, and is regulated under FDA 510(k) clearance (K913944). It operates as part of a gynecologic laparoscope accessory system, adhering to Class II medical device standards. The pump and associated components are supplied sterile and must be stored according to manufacturer guidelines to maintain sterility and functionality.

Other devices from American Surgical Instruments Corp.

Questions

AI-generated answers, 1 Oct 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 Nezhat/Dorsey Hydro Dissection Pump used for?

    The Nezhat/Dorsey Hydro Dissection Pump is designed specifically for gynecologic and laparoscopic surgical procedures. It facilitates tissue separation and fluid management by delivering pressurized irrigation fluids, which helps dissect delicate anatomical structures during minimally invasive surgeries, particularly in obstetrics and gynecology.

  • How is the Nezhat/Dorsey Hydro Dissection Pump supplied and what does this mean for its use?

    The pump and its accessories are supplied sterile, ensuring they are ready for immediate use in controlled surgical environments like operating rooms. This single-use design means each unit is intended for one surgical procedure only, reducing the risk of contamination and ensuring patient safety.

  • Is the Nezhat/Dorsey Hydro Dissection Pump reusable or intended for single-use?

    The device is explicitly designed for single-use only. This is a critical feature to maintain sterility and prevent cross-contamination between patients, aligning with best practices for surgical instruments in minimally invasive procedures.

  • How should the Nezhat/Dorsey Hydro Dissection Pump be stored to maintain its integrity?

    The pump must be stored according to the manufacturer’s guidelines to preserve sterility and functionality. Proper storage typically involves keeping it in its original packaging, in a clean, dry environment, away from direct sunlight or extreme temperatures, until the moment of use.

  • What regulatory pathway does the Nezhat/Dorsey Hydro Dissection Pump follow?

    The device is regulated under the FDA 510(k) clearance pathway, with the specific clearance number K913944. This classification ensures it meets Class II medical device standards, which are applicable to devices that present a moderate risk to patients.