Cleared Traditional

K770879 - BRONCHOFIBERSCOPE, FB-19A (FDA 510(k) Clearance)

K770879 · Pilling Co. · Gastroenterology & Urology device
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May 1977
Decision
9d
Days
-
Risk

K770879 is an FDA 510(k) clearance for the BRONCHOFIBERSCOPE, FB-19A.

Submitted by Pilling Co. (Mchenry, US). The FDA issued a Cleared decision on May 25, 1977 after a review of 9 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 Pilling Co. devices

Submission Details

510(k) Number K770879 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 16, 1977
Decision Date May 25, 1977
Days to Decision 9 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
121d faster than avg
Panel avg: 130d · This submission: 9d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code -
Device Class -