Cleared Traditional

K843348 - NISONSON WIRE & DRILL GUIDE SYS (FDA 510(k) Clearance)

K843348 · Stryker Corp. · General & Plastic Surgery device
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Oct 1984
Decision
65d
Days
-
Risk

K843348 is an FDA 510(k) clearance for the NISONSON WIRE & DRILL GUIDE SYS.

Submitted by Stryker Corp. (Kalamazoo, US). The FDA issued a Cleared decision on October 31, 1984 after a review of 65 days - a notably fast clearance cycle.

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: 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 Stryker Corp. devices

Submission Details

510(k) Number K843348 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 27, 1984
Decision Date October 31, 1984
Days to Decision 65 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
49d faster than avg
Panel avg: 114d · This submission: 65d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code -
Device Class -