Cleared Traditional

K840493 - SURG A STAT FINE TIP 5 (FDA 510(k) Clearance)

K840493 · Suncoast Medical Manufacturers, Inc. · Ophthalmic device
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Apr 1984
Decision
77d
Days
-
Risk

K840493 is an FDA 510(k) clearance for the SURG A STAT FINE TIP 5.

Submitted by Suncoast Medical Manufacturers, Inc. (Mchenry, US). The FDA issued a Cleared decision on April 23, 1984 after a review of 77 days - a notably fast clearance cycle.

This device falls under the Ophthalmic 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 Suncoast Medical Manufacturers, Inc. devices

Submission Details

510(k) Number K840493 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 06, 1984
Decision Date April 23, 1984
Days to Decision 77 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
33d faster than avg
Panel avg: 110d · This submission: 77d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code -
Device Class -