Cleared Traditional

K020882 - SHARPOINT ULTRAPLUG EXTENDED WEAR PLUG (FDA 510(k) Clearance)

K020882 · Surgical Specialties Corp · Ophthalmic device
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Optimized for regulatory review, auditing and printing
Jul 2002
Decision
130d
Days
-
Risk

K020882 is an FDA 510(k) clearance for the SHARPOINT ULTRAPLUG EXTENDED WEAR PLUG. Classified as Plug, Punctum (product code LZU).

Submitted by Surgical Specialties Corp (Reading, US). The FDA issued a Cleared decision on July 26, 2002 after a review of 130 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.

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Submission Details

510(k) Number K020882 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 18, 2002
Decision Date July 26, 2002
Days to Decision 130 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
20d slower than avg
Panel avg: 110d · This submission: 130d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LZU Plug, Punctum
Device Class -