Cleared Traditional

K954094 - OPHTA SIL- PUNCTAL PLUGS (MODIFICATION)

K954094 · G.W.B. Intl., Ltd. · Ophthalmic device
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Oct 1995
Decision
42d
Days
-
Risk

K954094 is an FDA 510(k) clearance for the OPHTA SIL- PUNCTAL PLUGS (MODIFICATION). Classified as Plug, Punctum (product code LZU).

Submitted by G.W.B. Intl., Ltd. (Marshfield, US). The FDA issued a Cleared decision on October 5, 1995 after a review of 42 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 G.W.B. Intl., Ltd. devices

FDA 510(k) Submission Details - K954094

510(k) Number K954094 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 24, 1995
Decision Date October 05, 1995
Days to Decision 42 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
68d faster than avg
Panel avg: 110d · This submission: 42d
Pathway characteristics
Predicate-based equivalence.

LZU Device Classification - Class 0,

Product Code LZU Plug, Punctum
Device Class -

Regulatory Peers - LZU Plug, Punctum

All 28
Devices cleared under the same product code (LZU) and FDA review panel - the closest regulatory comparables to K954094.
PUNCTUM PLUGS & READY-SET PUNCTAL PLUGS
K964774 · Fci Ophthalmics, Inc. · Dec 1996
READY-SET PUNCTAL PLUGS
K961909 · Fci Ophthalmics, Inc. · Jul 1996
VISITEC COLLAR BUTTON CATHETER {GRIFFITHS}
K953394 · Visitec Co. · Oct 1995
COLLAGEN INTRACANALICULAR PLUG
K946357 · Oasis Medical, Inc. · Feb 1995
SILICONE PUNCTAL PLUG
K945906 · Oasis Medical, Inc. · Jan 1995
VISITEC CANALICULAR STENT
K915809 · Visitec Co. · Feb 1992