Cleared Traditional

K811279 - AFTERLOADING CATHETER SET (FDA 510(k) Clearance)

K811279 · Mick Radio-Nuclear Instruments, Inc. · General & Plastic Surgery device
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Aug 1981
Decision
102d
Days
-
Risk

K811279 is an FDA 510(k) clearance for the AFTERLOADING CATHETER SET.

Submitted by Mick Radio-Nuclear Instruments, Inc. (Mchenry, US). The FDA issued a Cleared decision on August 18, 1981 after a review of 102 days - within the typical 510(k) review window.

This device falls under the General & Plastic Surgery FDA review panel. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all Mick Radio-Nuclear Instruments, Inc. devices

Submission Details

510(k) Number K811279 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 08, 1981
Decision Date August 18, 1981
Days to Decision 102 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
12d faster than avg
Panel avg: 114d · This submission: 102d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code -
Device Class -