BIOTOP HOOKSAFE LUER-LOCK SAFETY SYRINGE, MODELS 3CC/ML, 5CC/ML AND 10CC/ML— 510(k) K043038

Clearance details

Applicant

Biotop Technology Co., Ltd.

Product code

Code MEG

Device class

Class 2

Regulation

21 CFR 880.5860

Advisory panel

General Hospital

Date received

2004-11-04

Decision date

2004-12-22

Decision

Substantially Equivalent

Clearance type

Special

Location

Taipei, TW

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• K062318 — BIOTOP HOOKSAFE U-100 INSULIN SYRINGE, MODELS 0.5CC/ML AND 1CC/ML2007-01-03
• K041970 — BIOTOP HOOKSAFE SAFETY SYRINGE, MODELS 0.5CC/ML, 1CC/ML, 3CC/ML, 5CC/ML AND 10CC/ML2004-08-03
• K032747 — BIOTOP DJT-A SAFETY SYRINGE2004-05-11

Malfunction

1,373

Other

1

Total

1,374

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →