Cleared Traditional

K792206 - MEDTRONIC BURR HOLE PLUG & CAP (FDA 510(k) Clearance)

K792206 · Medtronic Vascular · Neurology device
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Nov 1979
Decision
23d
Days
-
Risk

K792206 is an FDA 510(k) clearance for the MEDTRONIC BURR HOLE PLUG & CAP.

Submitted by Medtronic Vascular (Walker, US). The FDA issued a Cleared decision on November 21, 1979 after a review of 23 days - a notably fast clearance cycle.

This device falls under the Neurology 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Medtronic Vascular devices

Submission Details

510(k) Number K792206 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 29, 1979
Decision Date November 21, 1979
Days to Decision 23 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
125d faster than avg
Panel avg: 148d · This submission: 23d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code -
Device Class -