FDA 510(k)

Newclip Patient-matched instrumentation non sterile PSI

K-Number: K250767 · 2025-10-01

Decision Date2025-10-01

Product CodePBF

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

Newclip Patient-matched instrumentation non sterile PSI is a medical device manufactured by Newclip Technics. It received FDA 510(k) clearance on 2025-10-01 under approval number K250767. The device is classified under product code PBF. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Newclip Patient-matched instrumentation non sterile PSI?

Newclip Patient-matched instrumentation non sterile PSI is a medical device that received FDA 510(k) clearance on 2025-10-01. It is manufactured by Newclip Technics. The 510(k) number is K250767.

When was Newclip Patient-matched instrumentation non sterile PSI approved by the FDA?

Newclip Patient-matched instrumentation non sterile PSI received FDA 510(k) clearance on 2025-10-01, under approval number K250767.

What company makes Newclip Patient-matched instrumentation non sterile PSI?

Newclip Patient-matched instrumentation non sterile PSI is manufactured by Newclip Technics.

What is the FDA product code for Newclip Patient-matched instrumentation non sterile PSI?

The FDA product code for Newclip Patient-matched instrumentation non sterile PSI is PBF.

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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.