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FDA 510(k)

AMERITEK SURE-POINT HDR NEEDLE TEMPLATE

K-Number: K031273 · 2003-07-15

ApplicantAmertek Medical, Inc.
Decision Date2003-07-15
Product CodeJAQ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

AMERITEK SURE-POINT HDR NEEDLE TEMPLATE is the device name listed in this FDA 510(k) record. The listed applicant is Amertek Medical, Inc.. It received FDA 510(k) clearance on 2003-07-15 under 510(k) number K031273. The device is classified under product code JAQ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AMERITEK SURE-POINT HDR NEEDLE TEMPLATE?

AMERITEK SURE-POINT HDR NEEDLE TEMPLATE is a medical device that received FDA 510(k) clearance on 2003-07-15. The listed applicant is Amertek Medical, Inc.. The 510(k) number is K031273.

When did AMERITEK SURE-POINT HDR NEEDLE TEMPLATE receive FDA 510(k) clearance?

AMERITEK SURE-POINT HDR NEEDLE TEMPLATE received FDA 510(k) clearance on 2003-07-15, under 510(k) number K031273.

Who is the listed applicant for AMERITEK SURE-POINT HDR NEEDLE TEMPLATE?

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

What is the FDA product code for AMERITEK SURE-POINT HDR NEEDLE TEMPLATE?

The FDA product code for AMERITEK SURE-POINT HDR NEEDLE TEMPLATE is JAQ.

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Other records listing Amertek Medical, 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.

K030518AMERITEK SURE-POINT TRACKER SYSTEMK011581AMERITEK BRACHYTHERAPY TEMPLATE

Related Devices (Code: JAQ)

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.

K262383LumenCare AzureNucletron B.V.K252717MAASTRO Rectal Applicator SetVarian Medical SystemsK251037Rectal ApplicatorNucletron B.V.K252884Guided Aarhus Applicator SetVarian Medical SystemsK250299CT/ MR Tandem and Ovoid SetVarian Medical Systems, Inc.K250289Intracavitary/Interstitial SystemVarian Medical Systems

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.

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