STOPCOCK— 510(k) K913560

Name: FDA 510(k) clearance K913560
Creator: U.S. Food and Drug Administration
Published: 1991-12-31

Substantially Equivalent

Graham Medical Products

FDA 510(k) clearance K913560 for STOPCOCK, Substantially Equivalent on 1991-12-31. Applicant: Graham Medical Products. Device class: 2.

Clearance details

Applicant: Graham Medical Products
Product code: Code FMG
Device class: Class 2
Regulation: 21 CFR 880.5440
Advisory panel: General Hospital
Date received: 1991-08-09
Decision date: 1991-12-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Holyoke, MA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code FMG

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K242255 — Qitexio® 4-Way Stopcock (QIT014)2025-04-29
K223499 — Three Way Stop Cock2023-07-21
K223175 — lntravascular Administration Sets with Stopcock and Manifold2023-03-10
K211204 — SafePort(TM) Manifold (or Stopcock)2022-09-15
K210516 — Clicky Cross2022-05-16

More clearances from Graham Medical Products

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K921657 — VASECTOMY DRAPE1993-03-18
K922100 — DISPOSABLE TURP FLUID CONTAINMENT DRAPE - STERILE1993-03-15
K922059 — DISPOSABLE CYSTOSCOPY SPLASH DRAPE-STERILE #5991993-03-03
K913447 — DISPOSABLE CYSTOSCOPY SPLASH DRAPE-STERILE #5991992-02-07
K913448 — DISPOSABLE TURP FLUID CONTAINMENT DRAPE - STERILE1992-02-07

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.