Cleared Traditional

K860977 - MODEL 545-45 FOR NEUROLOGICAL SURGICAL APPLICATION (FDA 510(k) Clearance)

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

K860977 · Britt Corp., Inc. · Neurology device
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Oct 1986
Decision
216d
Days
Class 3
Risk

K860977 is an FDA 510(k) clearance for the MODEL 545-45 FOR NEUROLOGICAL SURGICAL APPLICATION. Classified as Laser, Neurosurgical, Argon (product code LLF), Class III - Premarket Approval.

Submitted by Britt Corp., Inc. (Smithtown, US). The FDA issued a Cleared decision on October 16, 1986 after a review of 216 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.

View all Britt Corp., Inc. devices

Submission Details

510(k) Number K860977 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 14, 1986
Decision Date October 16, 1986
Days to Decision 216 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
68d slower than avg
Panel avg: 148d · This submission: 216d
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.