TOCOLYTIC SITE CARE SUP KIT #1001/100A/CARRY CASE— 510(k) K893003

Clearance details

Applicant

United Medical Systems, Inc.

Product code

Code FOZ

Device class

Class 2

Regulation

21 CFR 880.5200

Advisory panel

General Hospital

Date received

1989-04-24

Decision date

1989-07-14

Decision

Unknown

Clearance type

Traditional

Location

Santa Ana, CA, US

• K260432 — Ruby Intravascular Catheter2026-09-02
• K260165 — Unimpregnated Central Venous Catheter2026-08-10
• K261041 — ClearSafe Closed System2026-07-10
• K260539 — MedSource QuickSafe Safety IV Catheter; MedSource PurSafe Safety IV Catheter2026-07-09
• K253235 — Introcan Safety® Deep Access XL IV Catheter2026-05-15

• K072538 — PIEZOLITH 3000 TRIPLE-FOCUS LITHOTRIPTER2008-01-30
• K032958 — PIEZOLITH 3000 LITHOTRIPTER, MODEL 30002004-02-17
• K894949 — SQA1989-12-29
• K863645 — SCHULMAN DOUBLE UMBILICAL CORD CLAMP NO. 10001986-09-25

Death

38

Injury

2,290

Malfunction

25,858

Other

11

Total

28,197

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 →