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ProcedureKitCRF CRF-N1005-K

by Cambridge Interventional LLC

ProcedureKitCRF CRF-N1005-K is a Class II device made by Cambridge Interventional LLC, cleared under FDA 510(k) K192715 on 7 Jan 2020 and listed in FDA GUDID since 13 Jan 2026 (UDI-DI 00811746033838), active as of 22 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 22 Oct 2026

Documents

510(k) K192715

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00811746033838 UDI-DI Date13 Jan 2026ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK192715 Date7 Jan 2020DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K192715 decided 7 Jan 2020 Active
  • FDA GUDID UDI-DI 00811746033838 listed 13 Jan 2026 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K192715
  2. Listed FDA GUDID 00811746033838

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
ProcedureKitCRF
Generic name
Percutaneous radio-frequency ablation probe, tumour-ablation, monopolar
Model / Ref / Catalog
CRF-N1005-K
Primary DI / UDI-DI
00811746033838
510(k) Number
FDA product code
GEI
GMDN term
Percutaneous radio-frequency ablation probe, tumour-ablation, monopolar
Device class
Class II
Regulation number
878.4400
GUDID distribution status
In Commercial Distribution

Related devices

Cleared under the same submission (K192715)

and 8 more cleared under K192715

Similar devices

Other devices filed under FDA product code GEI (Electrosurgical, Cutting & Coagulation & Accessories).

Other devices from Cambridge Interventional LLC

See all devices from Cambridge Interventional LLC →

Properties

  • Single use
  • Prescription use
  • Convenience kit
  • Lot / batch number
  • Expiration date
Other properties (10, all answered No)