Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

ClearPoint Array System (Version 1.2)

K-Number: K232102 · 2023-09-15

ApplicantClearPoint Neuro, Inc.
Decision Date2023-09-15
Product CodeHAW
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

ClearPoint Array System (Version 1.2) is the device name listed in this FDA 510(k) record. The listed applicant is ClearPoint Neuro, Inc.. It received FDA 510(k) clearance on 2023-09-15 under 510(k) number K232102. The device is classified under product code HAW. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ClearPoint Array System (Version 1.2)?

ClearPoint Array System (Version 1.2) is a medical device that received FDA 510(k) clearance on 2023-09-15. The listed applicant is ClearPoint Neuro, Inc.. The 510(k) number is K232102.

When did ClearPoint Array System (Version 1.2) receive FDA 510(k) clearance?

ClearPoint Array System (Version 1.2) received FDA 510(k) clearance on 2023-09-15, under 510(k) number K232102.

Who is the listed applicant for ClearPoint Array System (Version 1.2)?

The FDA 510(k) record lists ClearPoint Neuro, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ClearPoint Array System (Version 1.2)?

The FDA product code for ClearPoint Array System (Version 1.2) is HAW.

Other records listing ClearPoint Neuro, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K243657ClearPoint System (Software Version 3.0)K233703Bone Anchor (NGS-BA-01)K233155ClearPointer Optical Navigation WandK233144ClearPoint Bone Screw FiducialsK233141SmartFrame ORK233243ClearPoint System (Software Version 2.2)

View all 11 devices →

Related Devices (Code: HAW)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261932Leksell® Vantage Stereotactic SystemElekta Solutions ABK253663Zeta Navigation SystemZeta Surgical, Inc.K253379Stealth AXiS Cranial clinical applicationMedtronic Navigation, Inc.K231897NeuroAlign softwareMedivis, Inc.K251317SOLOPASS 2.0 SystemIntravent Medical PartnersK250893Ball Joint Guide Array (66295)Bayer Medical Care, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑