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NanoKnife 20400103

by Angiodynamics, Inc. 2 variants

NanoKnife 20400103 is an irreversible electroporation system (FDA Class II; FDA product code OAB, Low energy direct current thermal ablation system) made by Angiodynamics, Inc., cleared under FDA 510(k) K150089 on 18 Jun 2015 and listed in FDA GUDID since 21 Sep 2016 (UDI-DI H787204001030), active as of 23 Oct 2026. One FDA recall is linked to it.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

1 closed

Documents

510(k) K150089

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 NumberH787204001030 UDI-DI Date21 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK150089 Date18 Jun 2015DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K150089 decided 18 Jun 2015 Active
  • FDA GUDID UDI-DI H787204001030 listed 21 Sep 2016 Listed

Recalls

1 recall · FDA

    • Terminated Z-0073-2022 FDA Class II initiated 24 Apr 2020

    Programming issue affected RFID function of a single lot and did not allow the NanoKnife probes to be recognized by the NanoKnife generator.

Timeline

3 dated events

  1. Cleared FDA 510(k) K150089
  2. Listed FDA GUDID H787204001030
  3. Recall initiated FDA recalls Z-0073-2022

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
NanoKnife
Generic name
Irreversible electroporation system
Model / reference
20400103
Primary DI / UDI-DI
H787204001030
510(k) Number
FDA product code
OAB
GMDN term
Irreversible electroporation system
Device class
Class II
Regulation number
878.4400
GUDID distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Size
Length — 15 Centimeter

Related devices

Category: Irreversible electroporation system

Cleared under the same submission (K150089)

and 5 more cleared under K150089

Similar devices

Other devices filed under FDA product code OAB (Low energy direct current thermal ablation system).

Other devices from Angiodynamics, Inc.

See all devices from Angiodynamics, Inc. →

Properties

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