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RNS® Tablet Kit 5001

by Neuropace, Inc.

RNS® Tablet Kit 5001 is a Class III device made by Neuropace, Inc., approved under FDA PMA P100026 on 14 Nov 2013 and listed in FDA GUDID since 15 Jan 2018 (UDI-DI 00855547005281), 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 P100026

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 Number00855547005281 UDI-DI Date15 Jan 2018ListedStatusListed GUDID: in commercial distribution
United StatesFDA PMAAPPR from GUDID Approved NumberP100026 Date14 Nov 2013DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA PMA P100026 decided 14 Nov 2013 Active
  • FDA GUDID UDI-DI 00855547005281 listed 15 Jan 2018 Listed

Timeline

2 dated events

  1. Approved FDA PMA P100026
  2. Listed FDA GUDID 00855547005281

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA PMA Active

Specification

GUDID

Trade name
RNS® Tablet Kit
Generic name
Brain-responsive electrical stimulation system
Model / reference
5001
Primary DI / UDI-DI
00855547005281
PMA number
FDA product code
PFN
GMDN term
Brain-responsive electrical stimulation system
Device class
Class III
GUDID distribution status
In Commercial Distribution
MRI safety
MR Unsafe

Related devices

Category: Brain-responsive electrical stimulation system

Cleared under the same submission (P100026)

and 8 more cleared under P100026

Other devices from Neuropace, Inc.

See all devices from Neuropace, Inc. →

Properties

  • Implantable
  • Serial number
Other properties (13, all answered No)