SECURODRIP— 510(k) K912660

Name: FDA 510(k) clearance K912660
Creator: U.S. Food and Drug Administration
Published: 1991-12-04

Substantially Equivalent

Op-Co Medical Products , Ltd.

FDA 510(k) clearance K912660 for SECURODRIP, Substantially Equivalent on 1991-12-04. Applicant: Op-Co Medical Products , Ltd.. Device class: 1.

Clearance details

Applicant: Op-Co Medical Products , Ltd.
Product code: Code KMK
Device class: Class 1
Regulation: 21 CFR 880.5210
Advisory panel: General Hospital
Date received: 1991-06-17
Decision date: 1991-12-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: New York, NY, US

Download summary PDF View on FDA.gov ↗

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K963365 — MULTI-PURPOSE MEDICAL TUBE HOLDER1996-10-11
K941098 — SECURE-SITE1995-08-09
K943147 — STATLOCK CV1994-09-29

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K932757 — SECURODRIP (TM) I.V. ARMBOARD1993-12-08

Adverse events under product code KMK

product code KMK

Malfunction: 461
Other: 1
Total: 462

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.