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Neuwave Rcpk

by NeuWave Medical, Inc.

Neuwave Rcpk is a medical device (FDA Class II; FDA product code NEY, System, Ablation, Microwave and Accessories) made by NeuWave Medical, Inc., cleared under FDA 510(k) K200081 on 13 Nov 2020 and listed in FDA GUDID since 28 Apr 2021 (UDI-DI 00818913020516), 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) K200081

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 Number00818913020516 UDI-DI Date28 Apr 2021ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK200081 Date13 Nov 2020DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K200081 decided 13 Nov 2020 Active
  • FDA GUDID UDI-DI 00818913020516 listed 28 Apr 2021 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K200081
  2. Listed FDA GUDID 00818913020516

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Neuwave
Generic name
Microwave ablation system probe planar-coagulation guide
Model / Ref / Catalog
RCPK
Primary DI / UDI-DI
00818913020516
510(k) Number
FDA product code
NEY
GMDN term
Microwave ablation system probe planar-coagulation guide
Device class
Class II
Regulation number
878.4400
GUDID distribution status
In Commercial Distribution
MRI safety
MR Unsafe

Related devices

Category: Microwave ablation system probe planar-coagulation guide

Similar devices

Other devices filed under FDA product code NEY (SYSTEM, ABLATION, MICROWAVE AND ACCESSORIES).

Other devices from NeuWave Medical, Inc.

See all devices from NeuWave Medical, Inc. →

Properties

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