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FDA 510(k)

NovaGuard SA Pro Safety System

K-Number: K163511 · 2017-02-02

ApplicantWest Pharmaceutical Services, Inc.
Decision Date2017-02-02
Product CodeMEG
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

NovaGuard SA Pro Safety System is a medical device manufactured by West Pharmaceutical Services, Inc.. It received FDA 510(k) clearance on 2017-02-02 under approval number K163511. The device is classified under product code MEG. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NovaGuard SA Pro Safety System?

NovaGuard SA Pro Safety System is a medical device that received FDA 510(k) clearance on 2017-02-02. It is manufactured by West Pharmaceutical Services, Inc.. The 510(k) number is K163511.

When was NovaGuard SA Pro Safety System approved by the FDA?

NovaGuard SA Pro Safety System received FDA 510(k) clearance on 2017-02-02, under approval number K163511.

What company makes NovaGuard SA Pro Safety System?

NovaGuard SA Pro Safety System is manufactured by West Pharmaceutical Services, Inc..

What is the FDA product code for NovaGuard SA Pro Safety System?

The FDA product code for NovaGuard SA Pro Safety System is MEG.

Related Clinical Trials

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Related PubMed Literature

PMID: 42168293 Comparative in vitro and in vivo assessment of three experimental extracellular matrix meshes for soft tissue remodeling. Scientific reports (2026) PMID: 42056377 Signal detection of adverse events in medical devices using natural language processing: a case study in pelvic mesh. Scientific reports (2026) PMID: 41734979 Strategies to Increase Patients' Adherence to Digital Therapeutics for Musculoskeletal Diseases: A Narrative Review. Yonsei medical journal (2026) PMID: 41619565 Integration of materiovigilance in Unani medicine: A step towards patient safety. Journal of Ayurveda and integrative medicine (2026)

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Related Devices (Code: MEG)

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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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