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FDA 510(k)

Disposable Needle Guides and Grids

K-Number: K223689 · 2023-08-02

ApplicantAdvance Medical Designs, Inc.
Decision Date2023-08-02
Product CodeITX
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Disposable Needle Guides and Grids is the device name listed in this FDA 510(k) record. The listed applicant is Advance Medical Designs, Inc.. It received FDA 510(k) clearance on 2023-08-02 under 510(k) number K223689. 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 Disposable Needle Guides and Grids?

Disposable Needle Guides and Grids is a medical device that received FDA 510(k) clearance on 2023-08-02. The listed applicant is Advance Medical Designs, Inc.. The 510(k) number is K223689.

When did Disposable Needle Guides and Grids receive FDA 510(k) clearance?

Disposable Needle Guides and Grids received FDA 510(k) clearance on 2023-08-02, under 510(k) number K223689.

Who is the listed applicant for Disposable Needle Guides and Grids?

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

What is the FDA product code for Disposable Needle Guides and Grids?

The FDA product code for Disposable Needle Guides and Grids is ITX.

Other records listing Advance Medical Designs, 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.

K163050Advance Medical Designs, Inc. Sterile Ultrasound Gel

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.

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.K250883ULTRASONIC PROBE UM-3R (UM-3R); ULTRASONIC PROBE UM-G20-29R (UM-G20-29R)Olympus Medical Systems Corporation

Official Source

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

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