NUOVOGUARD— 510(k) K090122

Clearance details

Applicant

U.S. Safety Syringes Co., Inc.

Product code

Code FOZ

Device class

Class 2

Regulation

21 CFR 880.5200

Advisory panel

General Hospital

Date received

2009-01-21

Decision date

2009-02-05

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Crofton, MD, 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

• K090502 — NOVA SAFE SCALP VEIN BLOOD COLLECTION SET2009-03-10
• K083454 — NUOVOCATH2008-12-04
• K080660 — IV ADMINISTRATION SET2008-05-13
• K080665 — NOVOLET2008-05-13
• K003381 — SHIELDING NEEDLE HOLDER2001-04-23

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 →