CENTURION STOPCOCK 3 WAY— 510(k) K810375

Name: FDA 510(k) clearance K810375
Creator: U.S. Food and Drug Administration
Published: 1981-02-26

Substantially Equivalent

Tri-State Hospital Supply Corp.

FDA 510(k) clearance K810375 for CENTURION STOPCOCK 3 WAY, Substantially Equivalent on 1981-02-26. Applicant: Tri-State Hospital Supply Corp.. Device class: 2.

Clearance details

Applicant: Tri-State Hospital Supply Corp.
Product code: Code FMG
Device class: Class 2
Regulation: 21 CFR 880.5440
Advisory panel: General Hospital
Date received: 1981-02-12
Decision date: 1981-02-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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K080448 — CENTURION PROTECTIVE RESTRAINT, SCR SERIES2008-08-28
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K942353 — CENTURION UMBILICAL CATHETER1995-08-15
K945977 — CENTURION(R) SITE GUARD(R) TRANSPARENT DRESSING/TRANSPAENT FILM DRESSING1995-03-29
K931748 — CENTLURION DISP STERI DENTAL/HYGIENE PACK/TRAYS1994-02-25

Adverse events under product code FMG

product code FMG

Death: 14
Malfunction: 3,433
Other: 1
Total: 3,448

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 →

Data sourced from openFDA. This site is unofficial and independent of the FDA.