Cleared Traditional

K881736 - SURGITEK CO2 DELIVERY SYSTEM

K881736 is the FDA 510(k) clearance for SURGITEK CO2 DELIVERY SYSTEM by Medical Engineering Corp.. It is a Class 2 Gastroenterology & Urology device (product code FAP) cleared through the Traditional 510(k) pathway after a 111-day FDA review.

K881736 · Medical Engineering Corp. · Gastroenterology & Urology device
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Aug 1988
Decision
111d
Days
Class 2
Risk

K881736 is an FDA 510(k) clearance for the SURGITEK CO2 DELIVERY SYSTEM. Classified as Cystometric Gas (carbon-dioxide) On Hydraulic Device (product code FAP), Class II - Special Controls.

Submitted by Medical Engineering Corp. (Racine, US). The FDA issued a Cleared decision on August 11, 1988 after a review of 111 days - within the typical 510(k) review window.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.1620 - 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 Medical Engineering Corp. devices

Submission Details

510(k) Number K881736 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 22, 1988
Decision Date August 11, 1988
Days to Decision 111 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
19d faster than avg
Panel avg: 130d · This submission: 111d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FAP Cystometric Gas (carbon-dioxide) On Hydraulic Device
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.1620
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 - FAP Cystometric Gas (carbon-dioxide) On Hydraulic Device

All 21
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