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FDA 510(k)

AFB (ABSORBABLE FOAM BUTTRESS)

K-Number: K014183 · 2002-06-12

ApplicantJ&J Corporate Biomaterials Center
Decision Date2002-06-12
Product CodeFTL
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

AFB (ABSORBABLE FOAM BUTTRESS) is the device name listed in this FDA 510(k) record. The listed applicant is J&J Corporate Biomaterials Center. It received FDA 510(k) clearance on 2002-06-12 under 510(k) number K014183. The device is classified under product code FTL. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AFB (ABSORBABLE FOAM BUTTRESS)?

AFB (ABSORBABLE FOAM BUTTRESS) is a medical device that received FDA 510(k) clearance on 2002-06-12. The listed applicant is J&J Corporate Biomaterials Center. The 510(k) number is K014183.

When did AFB (ABSORBABLE FOAM BUTTRESS) receive FDA 510(k) clearance?

AFB (ABSORBABLE FOAM BUTTRESS) received FDA 510(k) clearance on 2002-06-12, under 510(k) number K014183.

Who is the listed applicant for AFB (ABSORBABLE FOAM BUTTRESS)?

The FDA 510(k) record lists J&J Corporate Biomaterials Center as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AFB (ABSORBABLE FOAM BUTTRESS)?

The FDA product code for AFB (ABSORBABLE FOAM BUTTRESS) is FTL.

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Related Devices (Code: FTL)

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

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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