Cleared Traditional

K022043 - SMART PLUG, MODEL 500

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

FDA 510(k) Submission Details - K022043

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.

LZU Device Classification - Class 0,

Product Code LZU Plug, Punctum
Device Class -

Regulatory Peers - LZU Plug, Punctum

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