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FDA 510(k)

InterCollagen® Guide

K-Number: K223912 · 2023-08-17

ApplicantSigmagraft, Inc.
Decision Date2023-08-17
Product CodeNPL
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

InterCollagen® Guide is the device name listed in this FDA 510(k) record. The listed applicant is Sigmagraft, Inc.. It received FDA 510(k) clearance on 2023-08-17 under 510(k) number K223912. 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 InterCollagen® Guide?

InterCollagen® Guide is a medical device that received FDA 510(k) clearance on 2023-08-17. The listed applicant is Sigmagraft, Inc.. The 510(k) number is K223912.

When did InterCollagen® Guide receive FDA 510(k) clearance?

InterCollagen® Guide received FDA 510(k) clearance on 2023-08-17, under 510(k) number K223912.

Who is the listed applicant for InterCollagen® Guide?

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

What is the FDA product code for InterCollagen® Guide?

The FDA product code for InterCollagen® Guide is NPL.

Other records listing Sigmagraft, Inc. 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.

K221808InterOss Collagen

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

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

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