Company · CN
Well Lead Medical Co., Ltd.
FDA 510(k) clearances and medical device recalls filed under this name, 2009 to 2025. Name variants (Inc, Corp, punctuation) are merged.
17510(k) clearances (0 in 12 months)
1recalls (1 in 12 months)
1recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| BTR | Tube, Tracheal (W/Wo Connector) | 4 |
| EZD | Catheter, Straight | 3 |
| EZL | Catheter, Retention Type, Balloon | 3 |
| FED | Endoscopic Access Overtube, Gastroenterology-Urology | 3 |
| GBM | Catheter, Urethral | 1 |
| GCJ | Laparoscope, General & Plastic Surgery | 1 |
| KNT | Tubes, Gastrointestinal (And Accessories) | 1 |
| KOD | Catheter, Urological | 1 |
| ODC | Endoscope Channel Accessory | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Mar 5, 2025 | K241734 | Wellead® Hydrophilic Intermittent Catheter Ready to Use; Wellead® Hydrophilic Intermittent Catheter Compact Well Lead Medical Co., Ltd., CN | GBM |
| May 22, 2023 | K220722 | PVC Hydrophilic Urethral Catheter Well Lead Medical Co., Ltd., CN | EZD |
| Dec 16, 2022 | K220036 | Wellead Ureteral Catheter Well Lead Medical Co., Ltd., CN | KOD |
| Jul 21, 2022 | K211543 | Wei Nasal Jet Tube Well Lead Medical Co., Ltd., CN | BTR |
| Jan 14, 2022 | K211814 | Wellead Endoscopic Seal Well Lead Medical Co., Ltd., CN | ODC |
| Apr 8, 2021 | K202134 | Well Lead All Silicone Foley Catheter with Temperature Sensor Well Lead Medical Co., Ltd., CN | EZL |
| Dec 9, 2020 | K203119 | ClearPetra Suction-Evacuation Sheath Well Lead Medical Co., Ltd., CN | FED |
| Dec 11, 2019 | K182739 | Endotracheal Tube with Evacuation Lumen Well Lead Medical Co., Ltd., CN | BTR |
| Oct 11, 2017 | K162340 | Stomach Tube Well Lead Medical Co., Ltd., CN | KNT |
| Nov 29, 2016 | K160801 | Well Lead Extraction Bag Well Lead Medical Co., Ltd., CN | GCJ |
| Oct 12, 2016 | K161110 | ClearPetra Suction-Evacuation Sheath Well Lead Medical Co., Ltd., CN | FED |
| Jan 7, 2016 | K151084 | Well Lead Ureteral Access Sheath Well Lead Medical Co., Ltd., CN | FED |
| Dec 15, 2014 | K140667 | WELL LEAD HYDROPHILIC SILICONE FOLEY CATHETER Well Lead Medical Co., Ltd., CN | EZL |
| Oct 28, 2014 | K142563 | Well Lead PVC Urethral Catheter Well Lead Medical Co., Ltd., CN | EZD |
| Feb 24, 2014 | K133615 | WELL LEAD PVC HYDROPHILIC URETHRAL CATHETER Well Lead Medical Co., Ltd. | EZD |
| Aug 26, 2011 | K110269 | WELL LEAD ENDOTRACHEAL TUBE WITH EVACUATION LUMEN-ORAL Well Lead Medical Co., Ltd. | BTR |
| Oct 16, 2009 | K091516 | WELL LEAD SILICONE CATHETER WITH TEMPERATURE SENSOR Well Lead Medical Co., Ltd. | EZL |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 15, 2026 | WELL LEAD MEDICAL CO. LTD SunMed Tracheal Tube, Size 2.5; Model Number: 1-7333-25 Open, Classified |
BTR | K042683 |