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Genyx Flexible Injection Needle

by Geny Medical, Inc.

510(k) K001146

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 NumberK001146 Date30 Jun 2000ClearedStatusActive

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  • Withdrawn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
Genyx Flexible Injection Neeedle
510(k) Number
FDA Product Code
FBK
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.

An endoscopic injection needle is a device used to inject substances into tissue during endoscopic procedures. The Genyx Flexible Injection Needle is a flexible needle designed for endoscopic injection applications.

It is supplied as a sterile, single-use device intended for use in gastroenterology and urology settings. The device has FDA 510(k) clearance (K001146) under regulation 876.1500, product code FBK, and is classified as a Class II medical device.

Other devices from Geny Medical, Inc.