Cleared Traditional

K770523 - NEEDLE, BIOPSY, BOYD, LUNG (FDA 510(k) Clearance)

K770523 · Cook, Inc. · Pathology device
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Jun 1977
Decision
94d
Days
-
Risk

K770523 is an FDA 510(k) clearance for the NEEDLE, BIOPSY, BOYD, LUNG.

Submitted by Cook, Inc. (Mchenry, US). The FDA issued a Cleared decision on June 20, 1977 after a review of 94 days - within the typical 510(k) review window.

This device falls under the Pathology 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 Pathology review framework, consistent with the majority of Class II 510(k) submissions.

View all Cook, Inc. devices

Submission Details

510(k) Number K770523 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 18, 1977
Decision Date June 20, 1977
Days to Decision 94 days
Submission Type Traditional
Review Panel Pathology (PA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
17d slower than avg
Panel avg: 77d · This submission: 94d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code -
Device Class -