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510(k) K200071

Blue Beacon Submucosal Injectable Solution by Micro-Tech (Nanjing) Co., Ltd. — Product Code PLL

K200071 is an FDA 510(k) premarket notification submitted by Micro-Tech (Nanjing) Co., Ltd. for the device "Blue Beacon Submucosal Injectable Solution". The FDA issued a decision of Substantially Equivalent on November 3, 2020. The device falls under product code PLL (Submucosal Injection Agent), a Class II device regulated under 21 CFR 876.1500. Micro-Tech (Nanjing) Co., Ltd. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 3, 2020
Date Received
January 13, 2020
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Submucosal Injection Agent
Device Class
Class II
Regulation Number
876.1500
Review Panel
GU
Submission Type

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.

Other clearances by Micro-Tech (Nanjing) Co., Ltd.

  • K252492 — Visualized Access and Delivery Catheter; PB Digital Controller (April 24, 2026)
  • K251692 — Advanced Tissue Resection Device (February 21, 2026)
  • K250229 — Dual Action Tissue Closure Device (September 8, 2025)
  • K243388 — Disposable Distal Cap (June 27, 2025)
  • K243471 — Extraction Basket (December 16, 2024)
  • K230127 — Biliary Plastic Stent, Biliary Plastic Stent Introducer, Biliary Plastic Stent S (September 6, 2023)
  • K221784 — Single-use Video Pancreaticobiliary Scope, PB Digital Controller (February 16, 2023)
  • K222354 — Elastic Traction System (October 3, 2022)
  • K213060 — AreusTM Endobronchial Ultrasound Aspiration Needle, TridentTM Endobronchial Ultr (July 20, 2022)
  • K220424 — Through the Scope Tracheal Stent System (July 8, 2022)

Other clearances for product code PLL

  • K260997 — SIS BLU (SISBLU-30-01);SIS BLU (SISBLU-15-01) (September 9, 2026)
  • K241591 — Blue Eye (July 3, 2024)
  • K220434 — Blue Eye (TS-905) (August 12, 2022)
  • K221385 — LiftUp (Ref. Nr.: 200.56.01), LiftUp Kit (Ref. Nr.: 200.56.02) (August 11, 2022)
  • K202376 — EverLift Submucosal Lifting Agent (September 30, 2020)
  • K191923 — EverLift Submucosal Lifting Agent (June 20, 2020)
  • K191254 — EndoClot (January 30, 2020)
  • K180068 — ORISE Gel (September 28, 2018)
  • K150852 — SIC 8000 (September 3, 2015)

FDA data resources