Cleared Traditional

1070/15 TO 1078/17 VARIOUS TYPES NEEDLE HOLDERS

K851719 · Artiberia · Gastroenterology & Urology
Jul 1985
Decision
68d
Days
Class 3
Risk

About This 510(k) Submission

K851719 is an FDA 510(k) clearance for the 1070/15 TO 1078/17 VARIOUS TYPES NEEDLE HOLDERS, a Prosthesis, Vas Deferens (Class III — Premarket Approval, product code EZZ), submitted by Artiberia (San Antonio, US). The FDA issued a Cleared decision on July 2, 1985, 68 days after receiving the submission on April 25, 1985. This device falls under the Gastroenterology & Urology review panel.

Submission Details

510(k) Number K851719 FDA.gov
FDA Decision Cleared SESE
Date Received April 25, 1985
Decision Date July 02, 1985
Days to Decision 68 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary —

Device Classification

Product Code EZZ — Prosthesis, Vas Deferens
Device Class Class III — Premarket Approval