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510(k) K220247

Guidewire Locking Device by Micro-Tech (Nanjing) Co., Ltd. — Product Code ODC

K220247 is an FDA 510(k) premarket notification submitted by Micro-Tech (Nanjing) Co., Ltd. for the device "Guidewire Locking Device". The FDA issued a decision of Substantially Equivalent on March 29, 2022. The device falls under product code ODC (Endoscope Channel Accessory), 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
March 29, 2022
Date Received
January 28, 2022
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Endoscope Channel Accessory
Device Class
Class II
Regulation Number
876.1500
Review Panel
GU
Submission Type

To give the endoscope channel additional or improved functionality.

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 ODC

  • K252933 — DYNE PORT (June 12, 2026)
  • K250145 — Biopsy Port Adapter (October 17, 2025)
  • K252910 — Orca Air/Water and Suction Valves (October 9, 2025)
  • K250949 — Suction Valve (MAJ-1443); Air/Water Valve (MAJ-1444) (July 16, 2025)
  • K250732 — Disposable Endoscopy Valve Set (June 20, 2025)
  • K241842 — Luer-Split MAJ-2092 (March 19, 2025)
  • K250140 — Defendo Fujifilm 700 Single Use Cleaning Adapter (February 20, 2025)
  • K243075 — Defendo Single Use Cleaning Adapter for Olympus Endoscopes (100322, 100323, 4000 (November 8, 2024)
  • K242742 — DEFENDO Single Use Valve Kit AW/S Valves - 2pc for OLYMPUS EUS (00711900) (October 11, 2024)
  • K241285 — Disposable Endoscope Valves Set (AF series) (October 1, 2024)

FDA data resources