Cleared Traditional

K180068 - ORISE Gel

K180068 is the FDA 510(k) clearance for ORISE Gel by Boston Scientific. It is a Class 2 Gastroenterology & Urology device (product code PLL) cleared through the Traditional 510(k) pathway after a 262-day FDA review.

K180068 · Boston Scientific · Gastroenterology & Urology device
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Sep 2018
Decision
262d
Days
Class 2
Risk

K180068 is an FDA 510(k) clearance for the ORISE Gel. Classified as Submucosal Injection Agent (product code PLL), Class II - Special Controls.

Submitted by Boston Scientific (Marlboro, US). The FDA issued a Cleared decision on September 28, 2018 after a review of 262 days - an extended review cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.1500 - 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 K180068 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 09, 2018
Decision Date September 28, 2018
Days to Decision 262 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
132d slower than avg
Panel avg: 130d · This submission: 262d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code PLL Submucosal Injection Agent
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.1500
Definition Intended For Use In Gastrointestinal Endoscopic Procedures For Submucosal Lift Of Polyps, Adenomas, Early-stage Cancers Or Other Gastrointestinal Mucosal Lesions, Prior To Excision With A Snare Or Endoscopic Device.
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.