510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K043038Substantially Equivalent

Biotop Hooksafe Luer-Lock Safety Syringe, Models 3Cc/ml, 5Cc/ml and 10Cc/ml

Biotop Technology Co., Ltd., Taipei, TW / Special, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K043038 is the FDA 510(k) clearance record for BIOTOP HOOKSAFE LUER-LOCK SAFETY SYRINGE, MODELS 3CC/ML, 5CC/ML AND 10CC/ML, a class II device, cleared for Biotop Technology Co., Ltd. on under FDA product code MEG (Syringe, Antistick). FDA records list 4 510(k) clearances for Biotop Technology Co., Ltd., from to . As of , FDA records show no recalls naming K043038.

Clearance record

Decision date
Received
(48 days to decision)
Product code
MEG Syringe, Antistick
Regulation
21 CFR 880.5860
Device class
Class II
Review panel
General Hospital
Applicant
Biotop Technology Co., Ltd. 12 F-2, # 130, Taipei, TW
510(k) summary
Summary PDF
Third party review
No

Clearances, product code MEG

Trailing 12 months
2 clearances under product code MEG in the twelve months to October 2026, December 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code MEG, trailing twelve months
MonthClearances
November 20250
December 20251
January 20260
February 20261
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260