STRAIGHT AND RIGHT ANGLE NON-CORING NEEDLES— 510(k) K884211

Clearance details

Applicant

Marquette Medical, Inc.

Product code

Code FMI

Device class

Class 2

Regulation

21 CFR 880.5570

Advisory panel

General Hospital

Date received

1988-10-06

Decision date

1988-10-17

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Crofton, MD, US

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• K260739 — Profoject Pen Needles (Model A; Model B)2026-07-15

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• K920537 — SUBCUTANEOUS INFUSION SET1992-10-13
• K905218 — 4 LOW VOLUME IV EXTENSION SET WITH SLIDE CLAMP1991-06-04

Death

28

Injury

1,517

Malfunction

23,981

Other

18

Total

25,544

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 →