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rezum D2201

by Nxthera, Inc.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00855357006010 UDI-DI Date17 Jul 2017ListedStatusListed GUDID: in commercial distribution

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
rezum
Generic Name
Percutaneous radio-frequency ablation probe cannula, single-use
Model / Reference
D2201
Primary DI / UDI-DI
00855357006010
FDA Product Code
KNS
GMDN Term
Percutaneous radio-frequency ablation probe cannula, single-use
Device Class
Class II
Regulation Number
876.4300
GUDID distribution status
In Commercial Distribution

Related devices

Category: Percutaneous radio-frequency ablation probe cannula, single-use

Other devices from Nxthera, Inc.

  • Rezum System

    Class II

  • Rezum System

    Class II

  • Rezum System

    Class II

Properties

  • Sterile
  • Single Use
  • Prescription Use
  • Convenience Kit
  • Lot / Batch Number
  • Expiration Date

Other properties (8)

  • Implantable: No
  • Contains Latex: No
  • Over-the-Counter: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Manufacturing Date: No