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Nevro ACCK2100

by Nevro Corporation

Nevro ACCK2100 is a Class III device made by Nevro Corporation, approved under FDA PMA P130022 on 8 May 2015 and listed in FDA GUDID since 11 Jan 2020 (UDI-DI 00813426020411), active as of 22 Oct 2026.

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

PMA

Valid until

No expiry

PMA approval is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

PMA P130022

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 Number00813426020411 UDI-DI Date11 Jan 2020ListedStatusListed GUDID: in commercial distribution
United StatesFDA PMAAPPR from GUDID Approved NumberP130022 Date8 May 2015DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA PMA P130022 decided 8 May 2015 Active
  • FDA GUDID UDI-DI 00813426020411 listed 11 Jan 2020 Listed

Timeline

2 dated events

  1. Approved FDA PMA P130022
  2. Listed FDA GUDID 00813426020411

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA PMA Active

Specification

GUDID

Trade name
Nevro
Generic name
Neurosurgical procedure kit, non-medicated, single-use
Model / Ref / Catalog
ACCK2100
Primary DI / UDI-DI
00813426020411
PMA number
FDA product code
LGW
GMDN term
Neurosurgical procedure kit, non-medicated, single-use
Device class
Class III
GUDID distribution status
In Commercial Distribution

Related devices

Category: Neurosurgical procedure kit, non-medicated, single-use

Cleared under the same submission (P130022)

and 8 more cleared under P130022

Other devices from Nevro Corporation

See all devices from Nevro Corporation →

Properties

  • Supplied sterile
  • Single use
  • Prescription use
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (9, all answered No)