Home / 510(k) Clearances / K203119

510(k) K203119

ClearPetra Suction-Evacuation Sheath by Well Lead Medical Co., Ltd. — Product Code FED

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 9, 2020
Date Received
October 16, 2020
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Endoscopic Access Overtube, Gastroenterology-Urology
Device Class
Class II
Regulation Number
876.1500
Review Panel
GU
Submission Type

To facilitate passage and aid advancement of endoscopes into the body, especially in cases of repeated intubation.

Other clearances by Well Lead Medical Co., Ltd.

  • K241734 — Wellead® Hydrophilic Intermittent Catheter Ready to Use; Wellead® Hydrophilic In (March 5, 2025)
  • K220722 — PVC Hydrophilic Urethral Catheter (May 22, 2023)
  • K220036 — Wellead Ureteral Catheter (December 16, 2022)
  • K211543 — Wei Nasal Jet Tube (July 21, 2022)
  • K211814 — Wellead Endoscopic Seal (January 14, 2022)
  • K202134 — Well Lead All Silicone Foley Catheter with Temperature Sensor (April 8, 2021)
  • K182739 — Endotracheal Tube with Evacuation Lumen (December 11, 2019)
  • K162340 — Stomach Tube (October 11, 2017)
  • K160801 — Well Lead Extraction Bag (November 29, 2016)
  • K161110 — ClearPetra Suction-Evacuation Sheath (October 12, 2016)

Other clearances for product code FED

  • K252572 — Prodeon Urethral Sheath System (October 7, 2025)
  • K250128 — Single Use Suction-Evacuation Ureteral Access Sheath (September 19, 2025)
  • K250132 — Ureteral Access Sheath (September 5, 2025)
  • K250695 — Single-use Ureteral Access Sheath (July 8, 2025)
  • K251599 — Single-use Ureteral Access Sheath (July 3, 2025)
  • K250585 — LumenaTM Ureteral Access Sheath (June 27, 2025)
  • K250452 — CoralWell™ Single-use Ureteral Access Sheath (NS-0835B, NS-0840B, NS-0845B, NS-0 (June 2, 2025)
  • K243710 — Disposable ureteral access sheath (April 11, 2025)
  • K250517 — Navigator™ HD Ureteral Access Sheath Set 11/13 F x 28cm (M0062502210); Navigator (March 21, 2025)
  • K243820 — Hoover Negative Pressure Access Sheath (Hoover) (Hoover Model #'s IVX-NS-1040, I (January 31, 2025)