Cleared Traditional

ACCUPAC CUSTOM OPERATING ROOM PROCEDURE-DK876543 (K853265) - FDA 510(k) Clearance

K853265 · Geneva Laboratories, Inc. · General & Plastic Surgery device
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Aug 1985
Decision
21d
Days
-
Risk

K853265 is an FDA 510(k) clearance for the ACCUPAC CUSTOM OPERATING ROOM PROCEDURE-DK876543.

Submitted by Geneva Laboratories, Inc. (Elkhorn, US). The FDA issued a Cleared decision on August 26, 1985 after a review of 21 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 Geneva Laboratories, Inc. devices

Submission Details

510(k) Number K853265 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 05, 1985
Decision Date August 26, 1985
Days to Decision 21 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
94d faster than avg
Panel avg: 115d · This submission: 21d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code -
Device Class -