Pointer Tool (SS)

FDA UDI

Class II (US FDA UDI)

by Synaptive Medical Inc

Identity

Trade Name: Pointer Tool (SS) FDA UDI
Generic Name: Neurological stereotactic surgery system FDA UDI
Model / Reference: SYN-0013 FDA UDI

Identifiers

Primary DI / UDI-DI: 00670082000016 FDA UDI
510(k) Number: K153281 FDA UDI
FDA Product Code: HAW FDA UDI
GMDN Term: Neurological stereotactic surgery system FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 882.4560 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Neurological stereotactic surgery system

Pointer Tool (SS) by Synaptive Medical Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Cleared under the same submission

K153281 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Synaptive Medical Inc

Sources (1)

FDA UDI 787eeced-64dd-435d-85af-3b215406e2f6 33 fields · synced May 30, 2026