FDA 510(k)

Ancora-SB

K-Number: K231323 · 2023-08-31

Decision Date2023-08-31

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 2023-08-31 under 510(k) number K231323. 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 2023-08-31. The listed applicant is Aspero Medical, Inc.. The 510(k) number is K231323.

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

Ancora-SB received FDA 510(k) clearance on 2023-08-31, under 510(k) number K231323.

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.

K260314Ancora-SB

Related Devices (Code: FDA)

K260314Ancora-SBAspero Medical, Inc.K251204FUJIFILM Stiffening Wire Device (SW-2000)FUJIFILM Healthcare Americas Corporation K233321Double Balloon Endoscope EN-840T, Over-tube TS-1214CFUJIFILM Healthcare Americas Corporation K223295Endoscope Model EN-580T, Over-tube TS-1314B, Balloon BS-4, Tube Kit TY-500DFujifilm Corporaton K213195Balloon BS-3Fujifilm Corporation K191330Arc EnterocuffBoddingtons Plastics, Ltd.

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.