Cleared Traditional

MANAN PTC BIOPSY TRAYS (K852104) - FDA 510(k) Clearance

K852104 · Manan Manufacturing Co., Inc. · Gastroenterology & Urology device
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Jun 1985
Decision
35d
Days
-
Risk

K852104 is an FDA 510(k) clearance for the MANAN PTC BIOPSY TRAYS.

Submitted by Manan Manufacturing Co., Inc. (Skokie, US). The FDA issued a Cleared decision on June 19, 1985 after a review of 35 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology 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 Manan Manufacturing Co., Inc. devices

Submission Details

510(k) Number K852104 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received May 15, 1985
Decision Date June 19, 1985
Days to Decision 35 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
95d faster than avg
Panel avg: 130d · This submission: 35d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code -
Device Class -