FDA 510(k)

Ancora-SB

K-Number: K260314 · 2026-05-01

Decision Date2026-05-01

Product CodeFDA

Advisory CommitteeGU

DecisionSubstantially Equivalent

Device Summary

Ancora-SB is the device name listed in this FDA 510(k) record. The listed applicant is Aspero Medical, Inc.. It received FDA 510(k) clearance on 2026-05-01 under 510(k) number K260314. The device is classified under product code FDA. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Ancora-SB?

Ancora-SB is a medical device that received FDA 510(k) clearance on 2026-05-01. The listed applicant is Aspero Medical, Inc.. The 510(k) number is K260314.

When did Ancora-SB receive FDA 510(k) clearance?

Ancora-SB received FDA 510(k) clearance on 2026-05-01, under 510(k) number K260314.

Who is the listed applicant for Ancora-SB?

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

What is the FDA product code for Ancora-SB?

The FDA product code for Ancora-SB is FDA.

Other records listing Aspero 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.

K231323Ancora-SB

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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.