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Innervision Inc. Cannula/Trocar, Multiple Types

by Innervision, Inc.

510(k) K940731

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 NumberK940731 Date13 Sep 1994ClearedStatusActive

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  • Withdrawn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
Device Class
Class II
Regulation
21 CFR Part 876.1500
Advisory Committee
Gastroenterology, Urology
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.

The Innervision Inc. Cannula/Trocar is a medical device available in multiple types, designed for use in gastroenterology and urology procedures. It is a Class II device with product code GCJ, intended for diagnostic applications in general and plastic surgery.

This device is supplied as a single-use or reusable item, depending on the specific type, and is MRI safe. It is stored at room temperature and has received FDA 510(k) clearance with the K number K940731, deemed substantially equivalent to predicate devices.

Other devices from Innervision, 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 Innervision Inc. Cannula/Trocar used for?

    The Innervision Inc. Cannula/Trocar is designed for diagnostic applications in gastroenterology and urology procedures, as well as for use in general and plastic surgery. It is a Class II medical device with product code GCJ.

  • Is the Innervision Cannula/Trocar single-use or reusable?

    The Innervision Cannula/Trocar is available as either a single-use or reusable item, depending on the specific type selected. This flexibility allows for different clinical applications and preferences.

  • What regulatory approvals does the Innervision Cannula/Trocar have?

    The Innervision Cannula/Trocar has received FDA 510(k) clearance with K number K940731, deemed substantially equivalent to predicate devices. It is classified as a Class II device with product code GCJ.

  • How should the Innervision Cannula/Trocar be stored?

    The Innervision Cannula/Trocar should be stored at room temperature. Proper storage conditions help maintain the device's integrity and functionality until use.