Cleared Traditional

PRIA-KIT (TM) PRIAPISM KIT S.S. (K874000) - FDA 510(k) Clearance

Class I Gastroenterology & Urology device.

K874000 · Canton Medical, Inc. · Gastroenterology & Urology device
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Dec 1987
Decision
90d
Days
Class 1
Risk

K874000 is an FDA 510(k) clearance for the PRIA-KIT (TM) PRIAPISM KIT S.S.. Classified as Needle, Aspiration And Injection, Disposable (product code GAA), Class I - General Controls.

Submitted by Canton Medical, Inc. (Boston, US). The FDA issued a Cleared decision on December 30, 1987 after a review of 90 days - within the typical 510(k) review window.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 878.4800 - 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 Canton Medical, Inc. devices

Submission Details

510(k) Number K874000 FDA.gov
FDA Decision Cleared Substantially Equivalent - Direct De Novo (SESD)
Date Received October 01, 1987
Decision Date December 30, 1987
Days to Decision 90 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
40d faster than avg
Panel avg: 130d · This submission: 90d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code GAA Needle, Aspiration And Injection, Disposable
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 878.4800
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.

Regulatory Peers - GAA Needle, Aspiration And Injection, Disposable

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