MONOJECT HORIZONTAL ENTRY SHARPS CONTAINER— 510(k) K943485

Clearance details

Applicant

Sherwood Medical Co.

Product code

Code FMI

Device class

Class 2

Regulation

21 CFR 880.5570

Advisory panel

General Hospital

Date received

1994-07-19

Decision date

1994-09-09

Decision

Substantially Equivalent

Clearance type

Traditional

Location

St. Louis, MO, US

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• K261829 — Profoject Dual-Safety Pen Needles2026-07-29
• K260739 — Profoject Pen Needles (Model A; Model B)2026-07-15

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• K962880 — SENSI-TOUCH COMBO SPINAL/EPIDURAL REGIONAL ANESTHESIA DELIVERY SYSTEM1996-12-09
• K960574 — ARGYLE TURKEL NEONATAL/PEDIATRIC THORACIC CATHETER INSERTION TRAY AND THORACIC CATHETER SYSTEM1996-08-05
• K960677 — KANGAROO JEJUNAL FEEDING SYSTEM1996-05-13

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 →