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ClearPoint NGS-NC-09

by Clearpoint Neuro, Inc.

ClearPoint NGS-NC-09 is a Class I device made by Clearpoint Neuro, Inc., cleared under FDA 510(k) K102101 on 26 Jan 2011 and listed in FDA GUDID since 10 Mar 2026 (UDI-DI 00850047354716), 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) K102101

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 Number00850047354716 UDI-DI Date10 Mar 2026ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK102101 Date26 Jan 2011DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K102101 decided 26 Jan 2011 Active
  • FDA GUDID UDI-DI 00850047354716 listed 10 Mar 2026 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K102101
  2. Listed FDA GUDID 00850047354716

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  • Withdrawn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
Intracerebral cannula, nonimplantable, single-use
Model / Ref / Catalog
NGS-NC-09
Primary DI / UDI-DI
00850047354716
510(k) Number
FDA product code
HCD
GMDN term
Intracerebral cannula, nonimplantable, single-use
Device class
Class I
Regulation number
882.4060
GUDID distribution status
In Commercial Distribution
MRI safety
MR Safe

Related devices

Cleared under the same submission (K102101)

and 4 more cleared under K102101

Similar devices

Other devices filed under FDA product code HCD (Cannula, Ventricular).

Other devices from Clearpoint Neuro, Inc.

See all devices from Clearpoint Neuro, Inc. →

Properties

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