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FDA 510(k)

Kerecis Parvus (50207)

K-Number: K241080 · 2024-08-21

ApplicantKerecis Limited
Decision Date2024-08-21
Product CodeKGN
DecisionSubstantially Equivalent

Device Summary

Kerecis Parvus (50207) is the device name listed in this FDA 510(k) record. The listed applicant is Kerecis Limited. It received FDA 510(k) clearance on 2024-08-21 under 510(k) number K241080. The device is classified under product code KGN. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Kerecis Parvus (50207)?

Kerecis Parvus (50207) is a medical device that received FDA 510(k) clearance on 2024-08-21. The listed applicant is Kerecis Limited. The 510(k) number is K241080.

When did Kerecis Parvus (50207) receive FDA 510(k) clearance?

Kerecis Parvus (50207) received FDA 510(k) clearance on 2024-08-21, under 510(k) number K241080.

Who is the listed applicant for Kerecis Parvus (50207)?

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

What is the FDA product code for Kerecis Parvus (50207)?

The FDA product code for Kerecis Parvus (50207) is KGN.

Other records listing Kerecis Limited 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.

K251845Marigen Wound Extra; Kerecis Silicone; Kerecis ParvusK251844Kerecis SurgiBind (50241)K243843Tendon Protect (50242)K213904Kerecis OralK213231Kerecis SiliconeK202430Kerecis Reconstruct

View all 10 devices →

Related Devices (Code: KGN)

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.

K260596Collagen Wound PowderVentris MedicalK260669Endoform Dermal TemplateAroa Biosurgery , Ltd.K253521ECMT-100 WMDEcm Therapeutics, Inc.K253204CatalyzeBioTissue Holdings, Inc.K254034Roosin Collagen PowderRoosin Medical Co., Ltd.K253974Roosin Collagen DressingRoosin Medical Co., 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.

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