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Tru-Core Needle Set

by Ideamatrix

510(k) K943368

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 NumberK943368 Date29 Jul 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  • Withdrawn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
KNW
Device Class
Class II
Regulation
21 CFR Part 876.1075
Advisory Committee
Gastroenterology, Urology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 24 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 TRU-CORE NEEDLE SET is an Instrument, Biopsy device used in gastroenterology and urology procedures. It is designed for obtaining tissue samples during biopsy procedures.

The device is supplied as a needle set and has received FDA 510(k) clearance under K943368. It is classified as a Class II medical device with product code KNW and was cleared via the traditional pathway on July 29, 1994.

Other devices from Ideamatrix

Questions

AI-generated answers, 24 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 TRU-CORE NEEDLE SET used for?

    The TRU-CORE NEEDLE SET is designed for obtaining tissue samples during biopsy procedures in gastroenterology and urology, as it is an instrument specifically intended for tissue sampling in those clinical specialties.

  • How is the TRU-CORE NEEDLE SET supplied and is it reusable?

    The device is supplied as a needle set; however, the provided data does not specify whether it is single-use or reusable, so reuse status cannot be determined from the given information.

  • What regulatory pathway was used for the TRU-CORE NEEDLE SET clearance?

    The TRU-CORE NEEDLE SET received FDA 510(k) clearance under K943368 via the traditional pathway, as stated in the device data, and was cleared on July 29, 1994.