Cleared Traditional

SMART PLUG, MODEL 500 (K022043) - FDA 510(k) Clearance

Also marketed or referenced as:
SMARTPLUG FORCEPS, MODEL 502 PUSH ROD, MODEL 503
K022043 · Medennium, Inc. · Ophthalmic device
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Oct 2002
Decision
116d
Days
-
Risk

K022043 is an FDA 510(k) clearance for the SMART PLUG, MODEL 500. Classified as Plug, Punctum (product code LZU).

Submitted by Medennium, Inc. (Irvine, US). The FDA issued a Cleared decision on October 18, 2002 after a review of 116 days - within the typical 510(k) review window.

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 Medennium, Inc. devices

Submission Details

510(k) Number K022043 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 24, 2002
Decision Date October 18, 2002
Days to Decision 116 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
6d slower than avg
Panel avg: 110d · This submission: 116d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LZU Plug, Punctum
Device Class -