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510(k) K212748

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

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 20, 2022
Date Received
August 30, 2021
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.

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  • 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

  • K253734 — Taurus Clip (March 12, 2026)
  • K251562 — OTSCneo System Set (100.03n-14n, 100.27n-31n) (December 18, 2025)
  • K252271 — Hemoclip (November 12, 2025)
  • K250229 — Dual Action Tissue Closure Device (September 8, 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)
  • K234124 — Single Use Hemoclips (July 12, 2024)