Cleared Traditional

K964774 - PUNCTUM PLUGS & READY-SET PUNCTAL PLUGS

K964774 · Fci Ophthalmics, Inc. · Ophthalmic device
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Dec 1996
Decision
59d
Days
-
Risk

K964774 is an FDA 510(k) clearance for the PUNCTUM PLUGS & READY-SET PUNCTAL PLUGS. Classified as Plug, Punctum (product code LZU).

Submitted by Fci Ophthalmics, Inc. (Marshfield Hills, US). The FDA issued a Cleared decision on December 20, 1996 after a review of 59 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.

FDA 510(k) Submission Details - K964774

510(k) Number K964774 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 22, 1996
Decision Date December 20, 1996
Days to Decision 59 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
51d faster than avg
Panel avg: 110d · This submission: 59d
Pathway characteristics
Predicate-based equivalence.

LZU Device Classification - Class 0,

Product Code LZU Plug, Punctum
Device Class -

Regulatory Peers - LZU Plug, Punctum

All 45
Devices cleared under the same product code (LZU) and FDA review panel - the closest regulatory comparables to K964774.
PUNCTUAL OCCLUDER
K970631 · Odyssey Medical, Inc. · Apr 1997
HERRICK ULTIMATE PUNCTUM PLUG
K963501 · Lacrimedics, Inc. · Apr 1997
HERRICK ULTIMATE PUNCTUM PLUG
K963708 · Lacrimedics, Inc. · Apr 1997
READY-SET PUNCTAL PLUGS
K961909 · Fci Ophthalmics, Inc. · Jul 1996
VISITEC COLLAR BUTTON CATHETER {GRIFFITHS}
K953394 · Visitec Co. · Oct 1995
OPHTA SIL- PUNCTAL PLUGS (MODIFICATION)
K954094 · G.W.B. Intl., Ltd. · Oct 1995
K964774 · PUNCTUM PLUGS & READY-SET PUNCTAL PLUGS
Download PDF Fci Ophthalmics, Inc.