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FDA 510(k)

AMERITEK BRACHYTHERAPY TEMPLATE

K-Number: K011581 · 2001-07-17

ApplicantAmertek Medical, Inc.
Decision Date2001-07-17
Product CodeITX
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

AMERITEK BRACHYTHERAPY 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 2001-07-17 under 510(k) number K011581. The device is classified under product code ITX. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AMERITEK BRACHYTHERAPY TEMPLATE?

AMERITEK BRACHYTHERAPY TEMPLATE is a medical device that received FDA 510(k) clearance on 2001-07-17. The listed applicant is Amertek Medical, Inc.. The 510(k) number is K011581.

When did AMERITEK BRACHYTHERAPY TEMPLATE receive FDA 510(k) clearance?

AMERITEK BRACHYTHERAPY TEMPLATE received FDA 510(k) clearance on 2001-07-17, under 510(k) number K011581.

Who is the listed applicant for AMERITEK BRACHYTHERAPY 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 BRACHYTHERAPY TEMPLATE?

The FDA product code for AMERITEK BRACHYTHERAPY TEMPLATE is ITX.

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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.

K031273AMERITEK SURE-POINT HDR NEEDLE TEMPLATEK030518AMERITEK SURE-POINT TRACKER SYSTEM

Related Devices (Code: ITX)

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.

K260114Align® Cover and Pad Guidance ToolCIVCO Medical Instruments Co., Inc.K261170BA-004CCFujifilm CorporationK254143EM-TECH Passive Ultrasound Probe StrapEM-TECH Solutions, Inc.K260161SmartGuide Disposable Guides and GridsUC-CARE , Ltd.K262474ND Needle Guidance SystemAccurate Access, LLCK261014Accuro® 3S Needle Guide KitRivanna Medical, 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.

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