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FDA 510(k)

AUTO-DISABLE STERILE SAFTY SYRING FOR SINGLE USE

K-Number: K121637 · 2012-10-25

ApplicantSunwell Biotech Co., Ltd.
Decision Date2012-10-25
Product CodeMEG
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

AUTO-DISABLE STERILE SAFTY SYRING FOR SINGLE USE is the device name listed in this FDA 510(k) record. The listed applicant is Sunwell Biotech Co., Ltd.. It received FDA 510(k) clearance on 2012-10-25 under 510(k) number K121637. 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 AUTO-DISABLE STERILE SAFTY SYRING FOR SINGLE USE?

AUTO-DISABLE STERILE SAFTY SYRING FOR SINGLE USE is a medical device that received FDA 510(k) clearance on 2012-10-25. The listed applicant is Sunwell Biotech Co., Ltd.. The 510(k) number is K121637.

When did AUTO-DISABLE STERILE SAFTY SYRING FOR SINGLE USE receive FDA 510(k) clearance?

AUTO-DISABLE STERILE SAFTY SYRING FOR SINGLE USE received FDA 510(k) clearance on 2012-10-25, under 510(k) number K121637.

Who is the listed applicant for AUTO-DISABLE STERILE SAFTY SYRING FOR SINGLE USE?

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

What is the FDA product code for AUTO-DISABLE STERILE SAFTY SYRING FOR SINGLE USE?

The FDA product code for AUTO-DISABLE STERILE SAFTY SYRING FOR SINGLE USE is MEG.

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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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