Cleared Traditional

COOPER MEDICAL MODEL 770 (K833497) - FDA 510(k) Clearance

Class III device cleared through the 510(k) pathway via substantial equivalence to a legally marketed predicate.

K833497 · Cooper Medical Corp. · Neurology device
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Apr 1984
Decision
189d
Days
Class 3
Risk

K833497 is an FDA 510(k) clearance for the COOPER MEDICAL MODEL 770. Classified as Laser, Neurosurgical, Argon (product code LLF), Class III - Premarket Approval.

Submitted by Cooper Medical Corp. (Walker, US). The FDA issued a Cleared decision on April 17, 1984 after a review of 189 days - an extended review cycle.

This device falls under the Neurology 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: High-complexity regulatory submission. High regulatory complexity profile. This clearance follows a standard predicate-based equivalence path within the Neurology review framework, consistent with the majority of Class II 510(k) submissions.

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Submission Details

510(k) Number K833497 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 11, 1983
Decision Date April 17, 1984
Days to Decision 189 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
41d slower than avg
Panel avg: 148d · This submission: 189d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LLF Laser, Neurosurgical, Argon
Device Class Class 3 - Premarket Approval
What this classification means

Class III devices typically require Premarket Approval (PMA) with clinical evidence. Clearance through 510(k) for Class III devices is granted only when substantial equivalence to a valid predicate can be established.