Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

SwissGraft X

K-Number: K251613 · 2025-06-26

ApplicantGeistlich Pharma AG
Decision Date2025-06-26
Product CodeNPM
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

SwissGraft X is the device name listed in this FDA 510(k) record. The listed applicant is Geistlich Pharma AG. It received FDA 510(k) clearance on 2025-06-26 under 510(k) number K251613. The device is classified under product code NPM. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SwissGraft X?

SwissGraft X is a medical device that received FDA 510(k) clearance on 2025-06-26. The listed applicant is Geistlich Pharma AG. The 510(k) number is K251613.

When did SwissGraft X receive FDA 510(k) clearance?

SwissGraft X received FDA 510(k) clearance on 2025-06-26, under 510(k) number K251613.

Who is the listed applicant for SwissGraft X?

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

What is the FDA product code for SwissGraft X?

The FDA product code for SwissGraft X is NPM.

Other records listing Geistlich Pharma AG 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.

K260364Device 300419 StripK260532Derma-GideK251323Device 104 ParticulateK252253Geistlich Mucograft® /Geistlich Mucograft® Seal; Geistlich Fibro-Gide®K251062Geistlich 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 PackK251556Device 300423 Granules

View all 22 devices →

Related Devices (Code: NPM)

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.

K253723BOSSMedpark Co., Ltd.K251786Geistlich Bio-Oss®; Geistlich Bio-Oss Pen®Geistlich Pharma AGK242510Geistlich Bio-Flow®Geistlich Pharma AGK240133Xenograft Bovine Bone ParticulateCollagen Solutions, LLCK230305THE Graft CollagenPurgo Biologics, Inc.K240661Geistlich Bio-Oss®Geistlich Pharma AG

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.

↑