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FDA 510(k)

Nova Surface Applicator (ADPT-ONDEM-3DPRT-BRA)

K-Number: K241318 · 2024-08-30

ApplicantAdaptiiv Medical Technologies, Inc.
Decision Date2024-08-30
Product CodeMUJ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Nova Surface Applicator (ADPT-ONDEM-3DPRT-BRA) is the device name listed in this FDA 510(k) record. The listed applicant is Adaptiiv Medical Technologies, Inc.. It received FDA 510(k) clearance on 2024-08-30 under 510(k) number K241318. The device is classified under product code MUJ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Nova Surface Applicator (ADPT-ONDEM-3DPRT-BRA)?

Nova Surface Applicator (ADPT-ONDEM-3DPRT-BRA) is a medical device that received FDA 510(k) clearance on 2024-08-30. The listed applicant is Adaptiiv Medical Technologies, Inc.. The 510(k) number is K241318.

When did Nova Surface Applicator (ADPT-ONDEM-3DPRT-BRA) receive FDA 510(k) clearance?

Nova Surface Applicator (ADPT-ONDEM-3DPRT-BRA) received FDA 510(k) clearance on 2024-08-30, under 510(k) number K241318.

Who is the listed applicant for Nova Surface Applicator (ADPT-ONDEM-3DPRT-BRA)?

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

What is the FDA product code for Nova Surface Applicator (ADPT-ONDEM-3DPRT-BRA)?

The FDA product code for Nova Surface Applicator (ADPT-ONDEM-3DPRT-BRA) is MUJ.

Other records listing Adaptiiv Medical Technologies, 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.

K260308TrueFit BolusK243057TrueFit Bolus; TrueFlex Bolus

Related Devices (Code: MUJ)

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.

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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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