Cleared Traditional

K200071 - Blue Beacon Submucosal Injectable Solution (FDA 510(k) Clearance)

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

K200071 · Micro-Tech (Nanjing) Co., Ltd. · Gastroenterology & Urology device
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Nov 2020
Decision
295d
Days
Class 2
Risk

K200071 is an FDA 510(k) clearance for the Blue Beacon Submucosal Injectable Solution. Classified as Submucosal Injection Agent (product code PLL), Class II - Special Controls.

Submitted by Micro-Tech (Nanjing) Co., Ltd. (Nanjing, CN). The FDA issued a Cleared decision on November 3, 2020 after a review of 295 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.

View all Micro-Tech (Nanjing) Co., Ltd. devices

Submission Details

510(k) Number K200071 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 13, 2020
Decision Date November 03, 2020
Days to Decision 295 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
165d slower than avg
Panel avg: 130d · This submission: 295d
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.