Cleared Traditional

K030919 - SISS, INC. (D.B.A.MEDISISS) REPROCESSD ELECTROSURGICAL INSTRUMENTS AND ACCESSORIES (FDA 510(k) Clearance)

Class II Gastroenterology & Urology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K030919 · Medisiss · Gastroenterology & Urology device
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Optimized for regulatory review, auditing and printing
Jul 2003
Decision
101d
Days
Class 2
Risk

K030919 is an FDA 510(k) clearance for the SISS, INC. (D.B.A.MEDISISS) REPROCESSD ELECTROSURGICAL INSTRUMENTS AND ACCESS.... Classified as Unit, Electrosurgical, Endoscopic (with Or Without Accessories), Reprocessed (product code NLR), Class II - Special Controls.

Submitted by Medisiss (Sisters, US). The FDA issued a Cleared decision on July 3, 2003 after a review of 101 days - within the typical 510(k) review window.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.4300 - 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.

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Submission Details

510(k) Number K030919 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 24, 2003
Decision Date July 03, 2003
Days to Decision 101 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Regulatory Context
Review time vs. panel average
29d faster than avg
Panel avg: 130d · This submission: 101d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

Device Classification

Product Code NLR Unit, Electrosurgical, Endoscopic (with Or Without Accessories), Reprocessed
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.4300
Definition This Device Is Intended To Be Used Endoscopically To Remove Tissue And Control Bleeding By Use Of High Frequency Electrical Current. This Device Is Indicated For Reuse/reprocessing. Reprocessing Validation Data For This Device Type Must Be Included In A 510(k) Submission. (70 Fr 56911, Available At Https://www.govinfo.gov/content/pkg/fr-2005-09-29/pdf/05-19510.pdf).
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.