Cleared Traditional

IRRIGATION/ASPIRATION PACK (K832525) - FDA 510(k) Clearance

K832525 · Intermedics Intraocular, Inc. · General & Plastic Surgery device
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Oct 1983
Decision
67d
Days
-
Risk

K832525 is an FDA 510(k) clearance for the IRRIGATION/ASPIRATION PACK.

Submitted by Intermedics Intraocular, Inc. (Walker, US). The FDA issued a Cleared decision on October 4, 1983 after a review of 67 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery 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 Intermedics Intraocular, Inc. devices

Submission Details

510(k) Number K832525 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 29, 1983
Decision Date October 04, 1983
Days to Decision 67 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
48d faster than avg
Panel avg: 115d · This submission: 67d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code -
Device Class -