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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 a medical device manufactured by Sigmagraft, Inc.. It received FDA 510(k) clearance on 2023-08-17 under approval 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. It is manufactured by Sigmagraft, Inc.. The 510(k) number is K223912.

When was InterCollagen® Guide approved by the FDA?

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

What company makes InterCollagen® Guide?

InterCollagen® Guide is manufactured by Sigmagraft, Inc..

What is the FDA product code for InterCollagen® Guide?

The FDA product code for InterCollagen® Guide is NPL.

Other Devices by Sigmagraft, Inc.

K221808InterOss Collagen

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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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