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FDA 510(k)

Manual Tissue Removal Device

K-Number: K254050 · 2026-05-15

ApplicantSuzhou AcuVu Medical Technology Co., Ltd.
Decision Date2026-05-15
Product CodeHIH
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

Manual Tissue Removal Device is a medical device manufactured by Suzhou AcuVu Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2026-05-15 under approval number K254050. The device is classified under product code HIH. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Manual Tissue Removal Device?

Manual Tissue Removal Device is a medical device that received FDA 510(k) clearance on 2026-05-15. It is manufactured by Suzhou AcuVu Medical Technology Co., Ltd.. The 510(k) number is K254050.

When was Manual Tissue Removal Device approved by the FDA?

Manual Tissue Removal Device received FDA 510(k) clearance on 2026-05-15, under approval number K254050.

What company makes Manual Tissue Removal Device?

Manual Tissue Removal Device is manufactured by Suzhou AcuVu Medical Technology Co., Ltd..

What is the FDA product code for Manual Tissue Removal Device?

The FDA product code for Manual Tissue Removal Device is HIH.

Official Source

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