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FDA 510(k)

SaviSafe Safety Device

K-Number: K230287 · 2023-11-21

ApplicantSuzhou Savicred Biotechnology Co., Ltd.
Decision Date2023-11-21
Product CodeMEG
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

SaviSafe Safety Device is a medical device manufactured by Suzhou Savicred Biotechnology Co., Ltd.. It received FDA 510(k) clearance on 2023-11-21 under approval number K230287. 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 SaviSafe Safety Device?

SaviSafe Safety Device is a medical device that received FDA 510(k) clearance on 2023-11-21. It is manufactured by Suzhou Savicred Biotechnology Co., Ltd.. The 510(k) number is K230287.

When was SaviSafe Safety Device approved by the FDA?

SaviSafe Safety Device received FDA 510(k) clearance on 2023-11-21, under approval number K230287.

What company makes SaviSafe Safety Device?

SaviSafe Safety Device is manufactured by Suzhou Savicred Biotechnology Co., Ltd..

What is the FDA product code for SaviSafe Safety Device?

The FDA product code for SaviSafe Safety Device is MEG.

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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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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