Cleared Traditional

K841348 - UMBRELLA KEEL (FDA 510(k) Clearance)

K841348 · E. Benson Hood Laboratories, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1984
Decision
30d
Days
-
Risk

K841348 is an FDA 510(k) clearance for the UMBRELLA KEEL.

Submitted by E. Benson Hood Laboratories, Inc. (Mchenry, US). The FDA issued a Cleared decision on May 2, 1984 after a review of 30 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 E. Benson Hood Laboratories, Inc. devices

Submission Details

510(k) Number K841348 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 02, 1984
Decision Date May 02, 1984
Days to Decision 30 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
100d faster than avg
Panel avg: 130d · This submission: 30d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code -
Device Class -