Cleared Traditional

K950569 - OPHTA SIL {SELF-THREADING MONOKA (RITLENG TYPE)} (FDA 510(k) Clearance)

K950569 · G.W.B. Intl., Ltd. · Ophthalmic device
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Mar 1995
Decision
41d
Days
-
Risk

K950569 is an FDA 510(k) clearance for the OPHTA SIL {SELF-THREADING MONOKA (RITLENG TYPE)}. Classified as Plug, Punctum (product code LZU).

Submitted by G.W.B. Intl., Ltd. (Marshfield, US). The FDA issued a Cleared decision on March 14, 1995 after a review of 41 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.

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Submission Details

510(k) Number K950569 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 01, 1995
Decision Date March 14, 1995
Days to Decision 41 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
69d faster than avg
Panel avg: 110d · This submission: 41d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LZU Plug, Punctum
Device Class -