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FDA 510(k)

Kerecis Gingiva Graft

K-Number: K192612 · 2020-11-13

ApplicantKerecis Limited
Decision Date2020-11-13
Product CodeNPL
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Kerecis Gingiva Graft is the device name listed in this FDA 510(k) record. The listed applicant is Kerecis Limited. It received FDA 510(k) clearance on 2020-11-13 under 510(k) number K192612. The device is classified under product code NPL. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Kerecis Gingiva Graft?

Kerecis Gingiva Graft is a medical device that received FDA 510(k) clearance on 2020-11-13. The listed applicant is Kerecis Limited. The 510(k) number is K192612.

When did Kerecis Gingiva Graft receive FDA 510(k) clearance?

Kerecis Gingiva Graft received FDA 510(k) clearance on 2020-11-13, under 510(k) number K192612.

Who is the listed applicant for Kerecis Gingiva Graft?

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 Gingiva Graft?

The FDA product code for Kerecis Gingiva Graft is NPL.

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)K241080Kerecis Parvus (50207)K213904Kerecis OralK213231Kerecis Silicone

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Related Devices (Code: NPL)

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.

K242817Jason membraneBotiss Biomaterials GmbHK250512Augmented Gingival MatrixNeo Modulus (Suzhou) Medical Sci-Tech Co., Ltd.K252253Geistlich Mucograft® /Geistlich Mucograft® Seal; Geistlich Fibro-Gide®Geistlich Pharma AGK251062Geistlich Bio-Gide; Geistlich Bio-Gide® Shape; Geistlich Bio-Gide® Compressed; Geistlich Bio-Gide® Forte; Geistlich Bio-Gide® Perio; Geistlich Combi-Kit Collagen®; Geistlich Perio-System Combi PackGeistlich Pharma AGK250833SwissMembrane X; SwissMembrane X SocketGeistlich Pharma AGK233203Soft Tissue Augmentation Resorbable MatrixCollagen Matrix, Inc.

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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