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510(k) K250229

Dual Action Tissue Closure Device by Micro-Tech (Nanjing) Co., Ltd. — Product Code PKL

K250229 is an FDA 510(k) premarket notification submitted by Micro-Tech (Nanjing) Co., Ltd. for the device "Dual Action Tissue Closure Device". The FDA issued a decision of Substantially Equivalent on September 8, 2025. The device falls under product code PKL (Hemostatic Metal Clip For The Gi Tract), a Class II device regulated under 21 CFR 876.4400. Micro-Tech (Nanjing) Co., Ltd. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 8, 2025
Date Received
January 27, 2025
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Hemostatic Metal Clip For The Gi Tract
Device Class
Class II
Regulation Number
876.4400
Review Panel
GU
Submission Type

Clip placement within the gastrointestinal (GI) tract for the purpose of endoscopic marking, hemostasis for mucosal/sub-mucosal defects, bleeding ulcers, arteries, polyps, diverticula in the colon, prophylactic clipping, anchoring feeding tubes, supplemental closure method of luminal perforations.

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)
  • 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)
  • K220157 — Disposable Hemostatic Closure Clip Device (June 13, 2022)

Other clearances for product code PKL

  • K260580 — Single Use Reloadable Clip Applicator (HX-810LR, HX-810UR); Clip (HX-610-090, HX (May 21, 2026)
  • K252270 — Hemoclip (April 8, 2026)
  • K253734 — Taurus Clip (March 12, 2026)
  • K251562 — OTSCneo System Set (100.03n-14n, 100.27n-31n) (December 18, 2025)
  • K252271 — Hemoclip (November 12, 2025)
  • K250842 — PADLOCK CLIP EFTR Kit (00713229) (April 18, 2025)
  • K250066 — Resolution Clip (M00522600); Resolution Clip (M00522601); Resolution Clip (M0052 (February 6, 2025)
  • K241005 — Haemostasis Clips (January 2, 2025)
  • K240274 — PADLOCK CLIP EFTR Kit (00713229) (September 17, 2024)
  • K241858 — BARS Set (100.60) (August 26, 2024)

FDA data resources