Cleared Traditional

K827375 - BIOPSY GUIDE ATTACHMENT FOR USE WITH FETASCAN 2000 AND 2000A (FDA 510(k) Clearance)

K827375 · Cranbury Medical Labs, Inc. · Radiology device
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Jul 1982
Decision
80d
Days
-
Risk

K827375 is an FDA 510(k) clearance for the BIOPSY GUIDE ATTACHMENT FOR USE WITH FETASCAN 2000 AND 2000A.

Submitted by Cranbury Medical Labs, Inc. (Mchenry, US). The FDA issued a Cleared decision on July 2, 1982 after a review of 80 days - a notably fast clearance cycle.

This device falls under the Radiology 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 Cranbury Medical Labs, Inc. devices

Submission Details

510(k) Number K827375 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 13, 1982
Decision Date July 02, 1982
Days to Decision 80 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
27d faster than avg
Panel avg: 107d · This submission: 80d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code -
Device Class -