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Endopath Veress Needle

by Symbiosis Corp.

510(k) K910855

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 5 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 5 Oct 2026. What this means

Regulatory status

as of registry sync 5 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK910855 Date18 Apr 1991ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 5 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  • Withdrawn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
FHP
Device Class
Class II
Regulation
21 CFR Part 876.1500
Advisory Committee
Gastroenterology, Urology
FDA Decision
SESE Substantially Equivalent

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 Endopath Veress Needle is a simple insufflation needle (Product Code FHP) designed for creating pneumoperitoneum during minimally invasive surgical procedures, such as laparoscopy. It facilitates abdominal distension by safely introducing gas into the peritoneal cavity, enabling clearer visualization and access to internal structures. The device incorporates a spring-loaded, blunt stylet mechanism to enhance safety during insertion.

This device is supplied as a single-use, non-sterile instrument and is intended for use in gastroenterology and urology procedures. It must be sterilized prior to use and is classified under FDA Device Class II (876.1500). The Veress Needle is regulated under FDA 510(k) clearance (K910855) and is intended for use in controlled surgical environments. Storage and handling must comply with standard medical device protocols to maintain integrity.

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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 Endopath Veress Needle used for?

    The Endopath Veress Needle is designed specifically for creating pneumoperitoneum during minimally invasive surgical procedures, such as laparoscopy. It allows controlled introduction of gas into the peritoneal cavity, which helps distend the abdomen. This improves visualization and access to internal structures, making surgical tasks more precise and efficient.

  • Is the Endopath Veress Needle sterile as supplied?

    No, the Endopath Veress Needle is supplied as a single-use, non-sterile instrument. It must be sterilized prior to use in accordance with standard medical device protocols to ensure patient safety and device integrity.

  • What types of procedures is this needle intended for?

    This device is intended for use in gastroenterology and urology procedures, particularly those requiring laparoscopy. Its design ensures safe insufflation of gas into the peritoneal cavity, facilitating clearer surgical access.

  • How should the Endopath Veress Needle be stored?

    The Endopath Veress Needle must be stored in compliance with standard medical device protocols to maintain its integrity. Since it is non-sterile as supplied, it should be kept in a clean, dry environment away from direct sunlight or extreme temperatures until sterilization is performed.

  • Is this device reusable or single-use?

    The Endopath Veress Needle is intended for single-use only. After use, it should be discarded, as reuse is not recommended or supported by the manufacturer to ensure patient safety and device performance.