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Disposable Tissue Effect Biosensor-T

by Pan Dynamics Medical Corp.

510(k) K843157

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 NumberK843157 Date19 Sep 1984ClearedStatusActive

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  • Withdrawn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
FLL
Device Class
Class II
Regulation
21 CFR Part 880.2910
Advisory Committee
General Hospital
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.

Disposable Tissue Effect Biosensor-T is a disposable tissue effect biosensor. It is a medical device designed for the detection and measurement of tissue effects.

The device is supplied in a disposable, single-use format. It received FDA 510(k) clearance under K843157 and is classified under product code FLL. It is intended for use in general hospital settings.

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 Disposable Tissue Effect Biosensor-T used for?

    The Disposable Tissue Effect Biosensor-T is designed for the detection and measurement of tissue effects in general hospital settings, as stated in its description and intended use.

  • How is the Disposable Tissue Effect Biosensor-T supplied and is it reusable?

    The device is supplied in a disposable, single-use format, meaning it is intended for one-time use only and should not be reprocessed or reused after initial application.

  • What regulatory clearance does the Disposable Tissue Effect Biosensor-T have?

    The device received FDA 510(k) clearance under submission number K843157, which is explicitly stated in the authorizations and specifications sections of the device data.