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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 the device name listed in this FDA 510(k) record. The listed applicant is Suzhou Savicred Biotechnology Co., Ltd.. It received FDA 510(k) clearance on 2023-11-21 under 510(k) 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. The listed applicant is Suzhou Savicred Biotechnology Co., Ltd.. The 510(k) number is K230287.

When did SaviSafe Safety Device receive FDA 510(k) clearance?

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

Who is the listed applicant for SaviSafe Safety Device?

The FDA 510(k) record lists Suzhou Savicred Biotechnology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SaviSafe Safety Device?

The FDA product code for SaviSafe Safety Device is MEG.

Related Devices (Code: MEG)

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.

K252098PA3X Detachable Safety Sleeve Syringe (with needle) (SC-23ED / SD-23ED)Methyl Co., Ltd.K250847VaporShieldVault Paragon Group, Inc.K231165Shina Syringe; Shina Safety SyringeShina Med CorporationK231907Medline Safety Insulin and TB SyringesMedline Industries, LPK223376Monoject Magellan Insulin Safety Syringe 1mL, 31G x 6mm (8881893110); Monoject Magellan Insulin Safety Syringe 0.5mL, 31G x 6mm (8881893150); Monoject Magellan Insulin Safety Syringe 0.3mL, 31G x 6mm (8881893130)Cardinal Health200, LLCK220114PowerPAK SyringeVault Paragon Group, Inc.

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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