Cleared Traditional

BENDEREV PROTECT-A-PASS NEEDLE (K921228) - FDA 510(k) Clearance

Class I Gastroenterology & Urology device.

K921228 · Eimark Labs, Inc. · Gastroenterology & Urology device
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Sep 1992
Decision
185d
Days
Class 1
Risk

K921228 is an FDA 510(k) clearance for the BENDEREV PROTECT-A-PASS NEEDLE. Classified as Surgical Instruments, G-u, Manual (and Accessories) (product code KOA), Class I - General Controls.

Submitted by Eimark Labs, Inc. (Mission Viejo, US). The FDA issued a Cleared decision on September 14, 1992 after a review of 185 days - an extended review cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.4730 - the FDA gastroenterology and urology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. 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 Eimark Labs, Inc. devices

Submission Details

510(k) Number K921228 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 13, 1992
Decision Date September 14, 1992
Days to Decision 185 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
55d slower than avg
Panel avg: 130d · This submission: 185d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code KOA Surgical Instruments, G-u, Manual (and Accessories)
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 876.4730
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.