Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Ancora-SB

K-Number: K231323 · 2023-08-31

ApplicantAspero Medical, Inc.
Decision Date2023-08-31
Product CodeFDA
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Ancora-SB is a medical device manufactured by Aspero Medical, Inc.. It received FDA 510(k) clearance on 2023-08-31 under approval 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. It is manufactured by Aspero Medical, Inc.. The 510(k) number is K231323.

When was Ancora-SB approved by the FDA?

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

What company makes Ancora-SB?

Ancora-SB is manufactured by Aspero Medical, Inc..

What is the FDA product code for Ancora-SB?

The FDA product code for Ancora-SB is FDA.

Other Devices by Aspero Medical, Inc.

K260314Ancora-SB

Related Devices (Code: FDA)

K183032FUJIFILM Double Balloon Endoscope EI580BTFujifilm Corporation K183683FUJIFILM Double Balloon Endoscopes EN-580T, EC-450BI5, EN-450P5/20, and EN-450T5Fujifilm Corporation K191330Arc EnterocuffBoddingtons Plastics, Ltd. K213195Balloon BS-3Fujifilm Corporation K223295Endoscope Model EN-580T, Over-tube TS-1314B, Balloon BS-4, Tube Kit TY-500DFujifilm Corporaton K233321Double Balloon Endoscope EN-840T, Over-tube TS-1214CFUJIFILM Healthcare Americas Corporation

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.

↑