Biotop Hooksafe Luer-Lock Safety Syringe, Models 3cc/Ml, 5cc/Ml and 10cc/Ml

by Biotop Technology Co., Ltd. 510(k)

Active United States

510(k) K043038

Regulatory status

as of 29 Oct 2026

Region	Authorization	Number	Date	Status
United States	FDA 510(k)SESE Substantially Equivalent · Special	NumberK043038	Date22 Dec 2004Cleared	StatusActive

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

510(k)

510(k) Number: K043038
FDA Product Code: MEG
Models / Variants: 3cc
Ml
5cc
Ml
10cc
Ml

Device Class: Class II
Regulation: 21 CFR Part 880.5860
Advisory Committee: General Hospital
FDA Decision: SESE Substantially Equivalent

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