Cleared Traditional

K953394 - VISITEC COLLAR BUTTON CATHETER {GRIFFITHS} (FDA 510(k) Clearance)

K953394 · Visitec Co. · Ophthalmic device
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Oct 1995
Decision
87d
Days
-
Risk

K953394 is an FDA 510(k) clearance for the VISITEC COLLAR BUTTON CATHETER {GRIFFITHS}. Classified as Plug, Punctum (product code LZU).

Submitted by Visitec Co. (Sarasota, US). The FDA issued a Cleared decision on October 12, 1995 after a review of 87 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 Visitec Co. devices

Submission Details

510(k) Number K953394 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 17, 1995
Decision Date October 12, 1995
Days to Decision 87 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
23d faster than avg
Panel avg: 110d · This submission: 87d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LZU Plug, Punctum
Device Class -