Cleared Traditional

K963708 - HERRICK ULTIMATE PUNCTUM PLUG

K963708 · Lacrimedics, Inc. · Ophthalmic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1997
Decision
210d
Days
-
Risk

K963708 is an FDA 510(k) clearance for the HERRICK ULTIMATE PUNCTUM PLUG. Classified as Plug, Punctum (product code LZU).

Submitted by Lacrimedics, Inc. (Rialto, US). The FDA issued a Cleared decision on April 14, 1997 after a review of 210 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Ophthalmic review framework, consistent with the majority of Class II 510(k) submissions.

View all Lacrimedics, Inc. devices

FDA 510(k) Submission Details - K963708

510(k) Number K963708 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 16, 1996
Decision Date April 14, 1997
Days to Decision 210 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
100d slower than avg
Panel avg: 110d · This submission: 210d
Pathway characteristics
Predicate-based equivalence.

LZU Device Classification - Class 0,

Product Code LZU Plug, Punctum
Device Class -

Regulatory Peers - LZU Plug, Punctum

All 24
Devices cleared under the same product code (LZU) and FDA review panel - the closest regulatory comparables to K963708.
PUNCTUAL OCCLUDER
K972523 · Odyssey Medical, Inc. · Sep 1997
PUNCTUAL OCCLUDER
K970631 · Odyssey Medical, Inc. · Apr 1997
HERRICK ULTIMATE PUNCTUM PLUG
K963501 · Lacrimedics, Inc. · Apr 1997
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