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CellFX FG5004-01

by Pulse Biosciences, Inc

CellFX FG5004-01 (CTT0152) is an electrosurgical system (FDA Class II; FDA product code GEI, Electrosurgical, Cutting & Coagulation & Accessories) made by Pulse Biosciences, Inc, cleared under FDA 510(k) K203299 on 2 Feb 2021 and listed in FDA GUDID since 26 Feb 2021 (UDI-DI 00850003231600), active as of 8 Nov 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 8 Nov 2026

Documents

510(k) K203299

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 8 Nov 2026.

Regulatory status

as of registry sync 8 Nov 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00850003231600 UDI-DI Date26 Feb 2021ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK203299 Date2 Feb 2021DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K203299 decided 2 Feb 2021 Active
  • FDA GUDID UDI-DI 00850003231600 listed 26 Feb 2021 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K203299
  2. Listed FDA GUDID 00850003231600

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
CellFX
Generic name
Electrosurgical system
Model / Ref / Catalog
FG5004-01, CTT0152
Primary DI / UDI-DI
00850003231600
510(k) Number
FDA product code
GEI
GMDN term
Electrosurgical system
Device class
Class II
Regulation number
878.4400
GUDID distribution status
In Commercial Distribution
Sterilisation method
Ethylene Oxide

Related devices

Category: Electrosurgical system

Cleared under the same submission (K203299)

and 3 more cleared under K203299

Similar devices in this category

Other devices filed under Electrosurgical system.

Other devices from Pulse Biosciences, Inc

See all devices from Pulse Biosciences, Inc →

Properties

  • Supplied sterile
  • Sterilise before use
  • Single use
  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (9, all answered No)