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FDA 510(k)

Codman Surgical Patties & Strips

K-Number: K193346 · 2020-11-20

ApplicantIntegra LifeSciences Corporation
Decision Date2020-11-20
Product CodeHBA
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Codman Surgical Patties & Strips is the device name listed in this FDA 510(k) record. The listed applicant is Integra LifeSciences Corporation. It received FDA 510(k) clearance on 2020-11-20 under 510(k) number K193346. The device is classified under product code HBA. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Codman Surgical Patties & Strips?

Codman Surgical Patties & Strips is a medical device that received FDA 510(k) clearance on 2020-11-20. The listed applicant is Integra LifeSciences Corporation. The 510(k) number is K193346.

When did Codman Surgical Patties & Strips receive FDA 510(k) clearance?

Codman Surgical Patties & Strips received FDA 510(k) clearance on 2020-11-20, under 510(k) number K193346.

Who is the listed applicant for Codman Surgical Patties & Strips?

The FDA 510(k) record lists Integra LifeSciences Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Codman Surgical Patties & Strips?

The FDA product code for Codman Surgical Patties & Strips is HBA.

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Other records listing Integra LifeSciences Corporation 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.

PMA P850010Agent, absorbable hemostatic, collagen basedPMA P840062MATERIAL, DRESSING, SURGICAL, POLYLACTIC ACIDPMA P810006Agent, absorbable hemostatic, collagen basedPMA P080013Sealant, duralPMA P040034Sealant, duralPMA P900033Dressing, wound and burn, interactive

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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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