Cleared Traditional

K260997 - SIS BLU (SISBLU-30-01)

Also marketed or referenced as:
SIS BLU (SISBLU-15-01)

K260997 is an FDA 510(k) clearance for SIS BLU (SISBLU-30-01), manufactured by Endoclot Plus Co., Ltd.. The device is a Class 2 Gastroenterology & Urology device with product code PLL cleared through the Traditional 510(k) pathway after a 167-day FDA review.

K260997 · Endoclot Plus Co., Ltd. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2026
Decision
167d
Days
Class 2
Risk

K260997 is an FDA 510(k) clearance for the SIS BLU (SISBLU-30-01). Classified as Submucosal Injection Agent (product code PLL), Class II - Special Controls.

Submitted by Endoclot Plus Co., Ltd. (Suzhou, CN). The FDA issued a Cleared decision on September 9, 2026 after a review of 167 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 Endoclot Plus Co., Ltd. devices

FDA 510(k) Submission Details - K260997

510(k) Number K260997 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 26, 2026
Decision Date September 09, 2026
Days to Decision 167 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
36d slower than avg
Panel avg: 131d · This submission: 167d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

PLL Device Classification - Class 2, Special Controls

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.

Regulatory Consultant

Microkn Medical Technology Service (Shanghai) Co., Ltd.
Owen He

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - PLL Submucosal Injection Agent

All 9
Devices cleared under the same product code (PLL) and FDA review panel - the closest regulatory comparables to K260997.
Blue Eye
K241591 · The Standard Co., Ltd. · Jul 2024
Blue Eye (TS-905)
K220434 · The Standard Co., Ltd. · Aug 2022
LiftUp (Ref. Nr.: 200.56.01), LiftUp Kit (Ref. Nr.: 200.56.02)
K221385 · Ovesco Endoscopy AG · Aug 2022
Blue Beacon Submucosal Injectable Solution
K200071 · Micro-Tech (Nanjing) Co., Ltd. · Nov 2020
EverLift Submucosal Lifting Agent
K202376 · Gi Supply, Inc. · Sep 2020
EverLift Submucosal Lifting Agent
K191923 · Gi Supply · Jun 2020