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Tecno 150-100

by Tecno Instruments (Pvt.), Ltd.

Tecno 150-100 is a Class II device made by Tecno Instruments (Pvt.), Ltd., cleared under FDA 510(k) K002257 on 19 Oct 2000 and listed in FDA GUDID since 30 Jun 2021 (UDI-DI 08964000207000), active as of 23 Oct 2026.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 23 Oct 2026

Documents

510(k) K002257

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number08964000207000 UDI-DI Date30 Jun 2021ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK002257 Date19 Oct 2000DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K002257 decided 19 Oct 2000 Active
  • FDA GUDID UDI-DI 08964000207000 listed 30 Jun 2021 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K002257
  2. Listed FDA GUDID 08964000207000

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Tecno
Generic name
Electrosurgical handpiece, single-use
Model / reference
150-100
Primary DI / UDI-DI
08964000207000
510(k) Number
FDA product code
GEI
GMDN term
Electrosurgical handpiece, single-use
Device class
Class II
Regulation number
878.4400
GUDID distribution status
In Commercial Distribution

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Properties

  • Supplied sterile
  • Single use
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (10, all answered No)