Self-destruction Safety Syringes for Single Use +3 more— 510(k) K180417

Clearance details

Device name as filed

Self-destruction Safety Syringes for Single Use; Sterile Hypodermic Syringes for Single Use; Sterile Hypodermic Needles for Single Use; Sterile Safety Hypodermic Needles for Single Use

Applicant

Berpu Medical Technology Co., Ltd.

Product code

Code MEG

Device class

Class 2

Regulation

21 CFR 880.5860

Advisory panel

General Hospital

Date received

2018-02-15

Decision date

2018-08-09

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Wenzhou, CN

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• K250847 — VaporShield2025-12-12
• K230287 — SaviSafe Safety Device2023-11-21
• K231165 — Shina Syringe; Shina Safety Syringe2023-10-27
• K231907 — Medline Safety Insulin and TB Syringes2023-10-18

• K232165 — Sterile Safety Hypodermic Needles for Single Use +2 more2024-02-01
• K221045 — Insulin Syringes without needle2022-11-03
• K220061 — Safety Insulin Syringes2022-08-23
• K213158 — Syringe with permanently attached needle2022-07-21
• K213811 — Sterile Hypodermic Syringes for Single Use2022-05-12

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 →