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FDA 510(k)

Renova Spine Balloon Catheter

K-Number: K231340 · 2023-10-30

ApplicantBiopsybell S.R.L.
Decision Date2023-10-30
Product CodeNDN
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Renova Spine Balloon Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Biopsybell S.R.L.. It received FDA 510(k) clearance on 2023-10-30 under 510(k) number K231340. The device is classified under product code NDN. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Renova Spine Balloon Catheter?

Renova Spine Balloon Catheter is a medical device that received FDA 510(k) clearance on 2023-10-30. The listed applicant is Biopsybell S.R.L.. The 510(k) number is K231340.

When did Renova Spine Balloon Catheter receive FDA 510(k) clearance?

Renova Spine Balloon Catheter received FDA 510(k) clearance on 2023-10-30, under 510(k) number K231340.

Who is the listed applicant for Renova Spine Balloon Catheter?

The FDA 510(k) record lists Biopsybell S.R.L. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Renova Spine Balloon Catheter?

The FDA product code for Renova Spine Balloon Catheter is NDN.

Other records listing Biopsybell S.R.L. 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.

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Related Devices (Code: NDN)

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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