Cleared Traditional

K851719 - 1070/15 TO 1078/17 VARIOUS TYPES NEEDLE HOLDERS (FDA 510(k) Clearance)

Class III device cleared through the 510(k) pathway via substantial equivalence to a legally marketed predicate.

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

K851719 is an FDA 510(k) clearance for the 1070/15 TO 1078/17 VARIOUS TYPES NEEDLE HOLDERS. Classified as Prosthesis, Vas Deferens (product code EZZ), Class III - Premarket Approval.

Submitted by Artiberia (San Antonio, US). The FDA issued a Cleared decision on July 2, 1985 after a review of 68 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: High-complexity regulatory submission. High regulatory complexity profile. This clearance follows a standard predicate-based equivalence path within the Gastroenterology & Urology review framework, consistent with the majority of Class II 510(k) submissions.

View all Artiberia devices

Submission Details

510(k) Number K851719 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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 -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
62d faster than avg
Panel avg: 130d · This submission: 68d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code EZZ Prosthesis, Vas Deferens
Device Class Class 3 - Premarket Approval
What this classification means

Class III devices typically require Premarket Approval (PMA) with clinical evidence. Clearance through 510(k) for Class III devices is granted only when substantial equivalence to a valid predicate can be established.