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Gleeson Flo Vac & Selectone S/I Cannulae Model 60-6001, 6002, 6005

by Conmedcorp

510(k) K960562

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 NumberK960562 Date26 Apr 1996ClearedStatusActive

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  • Withdrawn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
GCJ
Models / Variants
Device Class
Class II
Regulation
21 CFR Part 876.1500
Advisory Committee
Gastroenterology, Urology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 6 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 Gleeson Flo Vac & Selectone S/I Cannulae Model 60-6001, 6002, 6005 is a laparoscopic cannula system classified under product code GCJ for general and plastic surgery applications. It is a substantially equivalent device cleared via the FDA 510(k) process under traditional review.

This device was submitted by Conmedcorp of Dayton, Ohio, and received FDA clearance on April 26, 1996, under K960562. It is intended for use in laparoscopic procedures within the specialties of gastroenterology and urology as indicated by the advisory committee review.

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Questions

AI-generated answers, 6 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 Gleeson Flo Vac & Selectone S/I Cannulae system used for?

    The Gleeson Flo Vac & Selectone S/I Cannulae system is intended for use in laparoscopic procedures within the specialties of gastroenterology and urology, as indicated by the advisory committee review during its FDA 510(k) submission.

  • How is the Gleeson Flo Vac & Selectone S/I Cannulae supplied and is it reusable?

    The device data does not specify whether the Gleeson Flo Vac & Selectone S/I Cannulae are supplied sterile or non-sterile, or whether they are designed for single-use or reuse; this information is not included in the provided specifications or description.

  • What models are included in the Gleeson Flo Vac & Selectone S/I Cannulae system?

    The Gleeson Flo Vac & Selectone S/I Cannulae system includes three models: 60-6001, 6002, and 6005, as explicitly stated in the device name and manufacturer listing.

  • What regulatory pathway was used to clear the Gleeson Flo Vac & Selectone S/I Cannulae?

    The Gleeson Flo Vac & Selectone S/I Cannulae were cleared via the FDA 510(k) process under traditional review, as confirmed by the decision description and clearance type in the device data.

  • Who manufactures the Gleeson Flo Vac & Selectone S/I Cannulae and where are they located?

    The Gleeson Flo Vac & Selectone S/I Cannulae are manufactured by Conmedcorp, located in Dayton, Ohio, United States, as indicated by the applicant, city, state, and country code fields in the device data.