Chrysalis Intelligence · Sponsors · Well Lead Medical Co., Ltd.

Well Lead Medical Co., Ltd.

Guangzhou, CN · 7 510(k) clearances

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Total clearances
7
2020-12-09 → 2025-03-05
Last 12 months
0
Product codes
7
Most recent
2025-03-05
Trend

Clearance cadence by quarter

Portfolio

Product codes worked

Code Device name Class Specialty Clearances Most recent
GBM Catheter, Urethral Class II Gastroenterology, Urology 1 2025-03-05
EZD Catheter, Straight Class II Gastroenterology, Urology 1 2023-05-22
KOD Catheter, Urological Class II Gastroenterology, Urology 1 2022-12-16
BTR — — — 1 2022-07-21
ODC Endoscope Channel Accessory Class II Gastroenterology, Urology 1 2022-01-14
EZL Catheter, Retention Type, Balloon Class II Gastroenterology, Urology 1 2021-04-08
FED Endoscopic Access Overtube, Gastroenterology-Urology Class II Gastroenterology, Urology 1 2020-12-09
Filings

All 510(k) clearances (7)

Date K-number Device Code Class Specialty
2025-03-05 K241734 Wellead® Hydrophilic Intermittent Catheter Ready to Use; Wellead® Hydrophilic Intermittent Catheter Compact GBM Class II Gastroenterology, Urology
2023-05-22 K220722 PVC Hydrophilic Urethral Catheter EZD Class II Gastroenterology, Urology
2022-12-16 K220036 Wellead Ureteral Catheter KOD Class II Gastroenterology, Urology
2022-07-21 K211543 Wei Nasal Jet Tube BTR — —
2022-01-14 K211814 Wellead Endoscopic Seal ODC Class II Gastroenterology, Urology
2021-04-08 K202134 Well Lead All Silicone Foley Catheter with Temperature Sensor EZL Class II Gastroenterology, Urology
2020-12-09 K203119 ClearPetra Suction-Evacuation Sheath FED Class II Gastroenterology, Urology
Data source: openFDA · Generated 2026-08-26 09:36 · Last ingest 2026-08-26T13:35:45.365163 · Pipeline: Chrysalis Intelligence