Well Lead Medical Co. Ltd
GUANGZHOU Guangdong, CN
WELL LEAD MEDICAL CO. LTD appears in FDA device records in GUANGZHOU Guangdong, CN. FDA records list 17 510(k) clearances between and , no PMA records and 2 registered establishments. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 17 510(k) clearances for Well Lead Medical Co. Ltd between 2009 and 2025. The busiest year on record is 2014, with 3. The most recent is 2025, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2009 | 1 |
| 2011 | 1 |
| 2014 | 3 |
| 2016 | 3 |
| 2017 | 1 |
| 2019 | 1 |
| 2020 | 1 |
| 2021 | 1 |
| 2022 | 3 |
| 2023 | 1 |
| 2025 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K241734 | Wellead® Hydrophilic Intermittent Catheter Ready to Use; Wellead® Hydrophilic Intermittent Catheter Compact | GBM | Substantially Equivalent | |
| K220722 | PVC Hydrophilic Urethral Catheter | EZD | Substantially Equivalent | |
| K220036 | Wellead Ureteral Catheter | KOD | Substantially Equivalent | |
| K211543 | Wei Nasal Jet Tube | BTR | Substantially Equivalent | |
| K211814 | Wellead Endoscopic Seal | ODC | Substantially Equivalent | |
| K202134 | Well Lead All Silicone Foley Catheter with Temperature Sensor | EZL | Substantially Equivalent | |
| K203119 | ClearPetra Suction-Evacuation Sheath | FED | Substantially Equivalent | |
| K182739 | Endotracheal Tube with Evacuation Lumen | BTR | Substantially Equivalent | |
| K162340 | Stomach Tube | KNT | Substantially Equivalent | |
| K160801 | Well Lead Extraction Bag | GCJ | Substantially Equivalent | |
| K161110 | ClearPetra Suction-Evacuation Sheath | FED | Substantially Equivalent | |
| K151084 | Well Lead Ureteral Access Sheath | FED | Substantially Equivalent | |
| K140667 | WELL LEAD HYDROPHILIC SILICONE FOLEY CATHETER | EZL | Substantially Equivalent | |
| K142563 | Well Lead PVC Urethral Catheter | EZD | Substantially Equivalent | |
| K133615 | WELL LEAD PVC HYDROPHILIC URETHRAL CATHETER | EZD | Substantially Equivalent | |
| K110269 | WELL LEAD ENDOTRACHEAL TUBE WITH EVACUATION LUMEN-ORAL | BTR | Substantially Equivalent | |
| K091516 | WELL LEAD SILICONE CATHETER WITH TEMPERATURE SENSOR | EZL | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3003903031 | 3003903031 | WELL LEAD MEDICAL CO. LTD | C-4 JINHU INDUSTRIAL ESTATE, GUANGZHOU Guangdong 511434 CN | 2026 | and 12 more, listed in full below |
| 3010400865 | 3010400865 | WELL LEAD MEDICAL CO. LTD | No. 47 Guomao Avenue South, GUANGZHOU Guangdong 511434 CN | 2026 | and 33 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- BTQAirway, Nasopharyngeal
- CAEAirway, Oropharyngeal, Anesthesiology
- OFPAnesthesia Breathing Circuit Kit (Adult & Pediatric)
- GCYApparatus, Suction, Single Patient Use, Portable, Nonpowered
- OIJBiopsy Needle Guide Kit
- KDQBottle, Collection, Vacuum
- CATCannula, Nasal, Oxygen
- JOLCatheter And Tip, Suction
- GBXCatheter, Irrigation
- GBWCatheter, Peritoneal
- EZLCatheter, Retention Type, Balloon
- EZDCatheter, Straight
- KOBCatheter, Suprapubic (And Accessories)
- EYBCatheter, Ureteral, Gastro-Urology
- GBMCatheter, Urethral
- KODCatheter, Urological
- BSYCatheters, Suction, Tracheobronchial
- CAICircuit, Breathing (W Connector, Adaptor, Y Piece)
- KNXCollector, Urine, (And Accessories) For Indwelling Catheter
- FLLContinuous Measurement Thermometer
- OGPCricothyrotomy Kit
- FAJCystoscope And Accessories, Flexible/Rigid
- FENDevice, Cystometric, Hydraulic
- NNXDevice, Incontinence, Urosheath Type, Non-Sterile
- KOEDilator, Urethral
- FFLDislodger, Stone, Basket, Ureteral, Metal
- ODCEndoscope Channel Accessory
- FEDEndoscopic Access Overtube, Gastroenterology-Urology
- OCYEndoscopic Guidewire, Gastroenterology-Urology
- FFDEvacuator, Bladder, Manually Operated
- PIFGastrointestinal Tubes With Enteral Specific Connectors
- FZXGuide, Surgical, Instrument
- FGAKit, Nephroscope
- GCJLaparoscope, General & Plastic Surgery
- FQHLavage, Jet
- BSJMask, Gas, Anesthetic
- BYGMask, Oxygen
- KGBMask, Oxygen, Non-Rebreathing
- BZOSet, Tubing And Support, Ventilator (W Harness)
- BSRStylet, Tracheal Tube
- FEGTube, Double Lumen For Intestinal Decompression And/Or Intubation
- BTRTube, Tracheal (W/Wo Connector)
- CBITube, Tracheal/Bronchial, Differential Ventilation (W/Wo Connector)
- BTOTube, Tracheostomy (W/Wo Connector)
- KNTTubes, Gastrointestinal (And Accessories)
- GAZTubing, Noninvasive
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain