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ClearPoint CP-FFSMPL-02

by Clearpoint Neuro, Inc.

ClearPoint CP-FFSMPL-02 is a Class II device made by Clearpoint Neuro, Inc., cleared under FDA 510(k) K091439 on 25 Aug 2009 and listed in FDA GUDID since 22 Jan 2021 (UDI-DI 00850376007390), active as of 22 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 22 Oct 2026

Documents

510(k) K091439

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 Number00850376007390 UDI-DI Date22 Jan 2021ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK091439 Date25 Aug 2009DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K091439 decided 25 Aug 2009 Active
  • FDA GUDID UDI-DI 00850376007390 listed 22 Jan 2021 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K091439
  2. Listed FDA GUDID 00850376007390

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
ClearPoint
Generic name
Skull clamp
Model / Ref / Catalog
CP-FFSMPL-02
Primary DI / UDI-DI
00850376007390
510(k) Number
FDA product code
HBL
GMDN term
Skull clamp
Device class
Class II
Regulation number
882.4460
GUDID distribution status
In Commercial Distribution
MRI safety
MR Safe

Related devices

Category: Skull clamp

Cleared under the same submission (K091439)

Other devices from Clearpoint Neuro, Inc.

See all devices from Clearpoint Neuro, Inc. →

Properties

  • Prescription use
  • Convenience kit
  • Lot / batch number
Other properties (12, all answered No)