Endoscopic Injection Needles— 510(k) K240675

Clearance details

Applicant

Promisemed Hangzhou Meditech Co., Ltd.

Product code

Code FBK

Device class

Class 2

Regulation

21 CFR 876.1500

Advisory panel

Gastroenterology, Urology

Date received

2024-03-11

Decision date

2024-10-04

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Hangzhou City, CN

• K260262 — Injection Needle2026-05-29
• K253598 — InjecSURE Injection System2026-03-31
• K252021 — Disposable Endoscopic Injection Needles2025-12-02
• K252247 — Injector Force Max Single Use Injector (4 models)2025-10-16
• K241595 — EzVu Visual Vasopressor injector (EV-19)2025-02-27

• K261719 — Promisemed X-Safety Pen Needle2026-08-25
• K261196 — Promisemed VeriEcto Automatic Biopsy Needles2026-05-12
• K261045 — Verifine Safety Lancets2026-05-01
• K254273 — Verisafe Safety Sterile Needles (SSN)2026-04-16
• K250192 — Verisafe Safety Retractable Insulin Syringes2025-12-10

Other

1

Total

1

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 →