Cleared Traditional

K970631 - PUNCTUAL OCCLUDER

K970631 · Odyssey Medical, Inc. · Ophthalmic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1997
Decision
63d
Days
-
Risk

K970631 is an FDA 510(k) clearance for the PUNCTUAL OCCLUDER. Classified as Plug, Punctum (product code LZU).

Submitted by Odyssey Medical, Inc. (Memphis, US). The FDA issued a Cleared decision on April 23, 1997 after a review of 63 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 Odyssey Medical, Inc. devices

FDA 510(k) Submission Details - K970631

510(k) Number K970631 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 19, 1997
Decision Date April 23, 1997
Days to Decision 63 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
47d faster than avg
Panel avg: 110d · This submission: 63d
Pathway characteristics
Predicate-based equivalence.

LZU Device Classification - Class 0,

Product Code LZU Plug, Punctum
Device Class -

Regulatory Peers - LZU Plug, Punctum

All 17
Devices cleared under the same product code (LZU) and FDA review panel - the closest regulatory comparables to K970631.
SURGIDEV SILICONE PUNCTUM PLUG
K980844 · Advanced Vision Science · May 1998
SILICONE PUNCTAL PLUG
K980437 · Oasis Medical, Inc. · Apr 1998
PUNCTUAL OCCLUDER
K972523 · Odyssey Medical, Inc. · Sep 1997
PUNCTUM PLUGS & READY-SET PUNCTAL PLUGS
K964774 · Fci Ophthalmics, Inc. · Dec 1996
VISITEC COLLAR BUTTON CATHETER {GRIFFITHS}
K953394 · Visitec Co. · Oct 1995
COLLAGEN INTRACANALICULAR PLUG
K946357 · Oasis Medical, Inc. · Feb 1995