Cleared Traditional

K935643 - SYRIGENE ACETIC ACID PRE-FILLEDSYRINGE

K935643 is an FDA 510(k) clearance for SYRIGENE ACETIC ACID PRE-FILLEDSYRINGE, manufactured by Regulatory & Marketing Services, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code KNY cleared through the Traditional 510(k) pathway after a 196-day FDA review.

K935643 · Regulatory & Marketing Services, Inc. · Gastroenterology & Urology device
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Jun 1994
Decision
196d
Days
Class 2
Risk

K935643 is an FDA 510(k) clearance for the SYRIGENE ACETIC ACID PRE-FILLEDSYRINGE. Classified as Accessories, Catheter, G-u (product code KNY), Class II - Special Controls.

Submitted by Regulatory & Marketing Services, Inc. (Palm Florida, US). The FDA issued a Cleared decision on June 10, 1994 after a review of 196 days - an extended review cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5130 - 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 Regulatory & Marketing Services, Inc. devices

FDA 510(k) Submission Details - K935643

510(k) Number K935643 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 26, 1993
Decision Date June 10, 1994
Days to Decision 196 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
65d slower than avg
Panel avg: 131d · This submission: 196d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KNY Device Classification - Class 2, Special Controls

Product Code KNY Accessories, Catheter, G-u
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5130
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Gastroenterology & Urology devices follow this clearance model.

Regulatory Peers - KNY Accessories, Catheter, G-u

All 30
Devices cleared under the same product code (KNY) and FDA review panel - the closest regulatory comparables to K935643.
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URINARY CARE SUPPLIES
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