Cleared Traditional

K980844 - SURGIDEV SILICONE PUNCTUM PLUG

K980844 · Advanced Vision Science · Ophthalmic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1998
Decision
68d
Days
-
Risk

K980844 is an FDA 510(k) clearance for the SURGIDEV SILICONE PUNCTUM PLUG. Classified as Plug, Punctum (product code LZU).

Submitted by Advanced Vision Science (Goleta, US). The FDA issued a Cleared decision on May 11, 1998 after a review of 68 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 Advanced Vision Science devices

FDA 510(k) Submission Details - K980844

510(k) Number K980844 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 04, 1998
Decision Date May 11, 1998
Days to Decision 68 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
42d faster than avg
Panel avg: 110d · This submission: 68d
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 K980844.
PDO Absorbable Punctum Plug
K150288 · Riverpoint Medical · Aug 2015
SHARPOINT ULTRAPLUG EXTENDED WEAR PLUG
K020882 · Surgical Specialties Corp · Jul 2002
SOFT PLUG ABSORBABLE PLUG-SA
K013613 · Oasis Medical, Inc. · Jun 2002
SILICONE PUNCTAL PLUG
K980437 · Oasis Medical, Inc. · Apr 1998
PUNCTUAL OCCLUDER
K972523 · Odyssey Medical, Inc. · Sep 1997
PUNCTUAL OCCLUDER
K970631 · Odyssey Medical, Inc. · Apr 1997