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FDA 510(k)

Surecan Safety II Needle, Surecan Safety II Needle, Surecan Safety II Needle with Caresite Luer Access Device and Y site

K-Number: K170897 · 2017-11-03

ApplicantB.Braun Medical, Inc.
Decision Date2017-11-03
Product CodePTI
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Surecan Safety II Needle, Surecan Safety II Needle, Surecan Safety II Needle with Caresite Luer Access Device and Y site is a medical device manufactured by B.Braun Medical, Inc.. It received FDA 510(k) clearance on 2017-11-03 under approval number K170897. The device is classified under product code PTI. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Surecan Safety II Needle, Surecan Safety II Needle, Surecan Safety II Needle with Caresite Luer Access Device and Y site?

Surecan Safety II Needle, Surecan Safety II Needle, Surecan Safety II Needle with Caresite Luer Access Device and Y site is a medical device that received FDA 510(k) clearance on 2017-11-03. It is manufactured by B.Braun Medical, Inc.. The 510(k) number is K170897.

When was Surecan Safety II Needle, Surecan Safety II Needle, Surecan Safety II Needle with Caresite Luer Access Device and Y site approved by the FDA?

Surecan Safety II Needle, Surecan Safety II Needle, Surecan Safety II Needle with Caresite Luer Access Device and Y site received FDA 510(k) clearance on 2017-11-03, under approval number K170897.

What company makes Surecan Safety II Needle, Surecan Safety II Needle, Surecan Safety II Needle with Caresite Luer Access Device and Y site?

Surecan Safety II Needle, Surecan Safety II Needle, Surecan Safety II Needle with Caresite Luer Access Device and Y site is manufactured by B.Braun Medical, Inc..

What is the FDA product code for Surecan Safety II Needle, Surecan Safety II Needle, Surecan Safety II Needle with Caresite Luer Access Device and Y site?

The FDA product code for Surecan Safety II Needle, Surecan Safety II Needle, Surecan Safety II Needle with Caresite Luer Access Device and Y site is PTI.

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Related PubMed Literature

PMID: 42181028 Systematic biocompatibility assessment of 4-µm surface silicone implants. Biomaterials and biosystems (2026) PMID: 42065230 The need of innovation and of preservation of well-established techniques in the era of MDR for improving outcomes. EFORT open reviews (2026) PMID: 42024289 Signal Detection Using Change Point Analysis to Identify Safety Signals from Spontaneous Reports in Aortic Stent Grafts in Japan. Journal of medical systems (2026) PMID: 41982627 Cybersecurity breaches in medical devices: analyzing FDA safety communications in response to patient security concerns. Frontiers in digital health (2026)

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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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