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FDA 510(k)

SafeLan® (2 models/SafeLan 26G, SafeLan 30G), SafeLan®-Pro (1 model/SafeLan®-Pro)

K-Number: K230759 · 2023-06-13

ApplicantBosungmeditech Co., Ltd.
Decision Date2023-06-13
Product CodeQRK
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

SafeLan® (2 models/SafeLan 26G, SafeLan 30G), SafeLan®-Pro (1 model/SafeLan®-Pro) is a medical device manufactured by Bosungmeditech Co., Ltd.. It received FDA 510(k) clearance on 2023-06-13 under approval number K230759. The device is classified under product code QRK. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SafeLan® (2 models/SafeLan 26G, SafeLan 30G), SafeLan®-Pro (1 model/SafeLan®-Pro)?

SafeLan® (2 models/SafeLan 26G, SafeLan 30G), SafeLan®-Pro (1 model/SafeLan®-Pro) is a medical device that received FDA 510(k) clearance on 2023-06-13. It is manufactured by Bosungmeditech Co., Ltd.. The 510(k) number is K230759.

When was SafeLan® (2 models/SafeLan 26G, SafeLan 30G), SafeLan®-Pro (1 model/SafeLan®-Pro) approved by the FDA?

SafeLan® (2 models/SafeLan 26G, SafeLan 30G), SafeLan®-Pro (1 model/SafeLan®-Pro) received FDA 510(k) clearance on 2023-06-13, under approval number K230759.

What company makes SafeLan® (2 models/SafeLan 26G, SafeLan 30G), SafeLan®-Pro (1 model/SafeLan®-Pro)?

SafeLan® (2 models/SafeLan 26G, SafeLan 30G), SafeLan®-Pro (1 model/SafeLan®-Pro) is manufactured by Bosungmeditech Co., Ltd..

What is the FDA product code for SafeLan® (2 models/SafeLan 26G, SafeLan 30G), SafeLan®-Pro (1 model/SafeLan®-Pro)?

The FDA product code for SafeLan® (2 models/SafeLan 26G, SafeLan 30G), SafeLan®-Pro (1 model/SafeLan®-Pro) is QRK.

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Related PubMed Literature

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Official Source

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