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Rf-Dgp-Iz

by St. Jude Medical, Inc.

Rf-Dgp-Iz is a Class II device made by St. Jude Medical, Inc., cleared under FDA 510(k) K203293 on 21 Jan 2022 and listed in FDA GUDID since 26 Mar 2024 (UDI-DI 05415067049650), 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) K203293

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 Number05415067049650 UDI-DI Date26 Mar 2024ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK203293 Date21 Jan 2022DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K203293 decided 21 Jan 2022 Active
  • FDA GUDID UDI-DI 05415067049650 listed 26 Mar 2024 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K203293
  2. Listed FDA GUDID 05415067049650

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Generic name
Electrosurgical return electrode, single-use
Model / Ref / Catalog
RF-DGP-IZ
Primary DI / UDI-DI
05415067049650
510(k) Number
FDA product code
GXD
GMDN term
Electrosurgical return electrode, single-use
Device class
Class II
Regulation number
882.4400
GUDID distribution status
In Commercial Distribution

Similar devices in this category

Other devices filed under Electrosurgical return electrode, single-use.

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Properties

  • Single use
  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (11, all answered No)