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510(k) Data Aggregation
K Number
K241734Device Name
Wellead® Hydrophilic Intermittent Catheter Ready to Use; Wellead® Hydrophilic Intermittent Catheter Compact
Manufacturer
Well Lead Medical Co., Ltd.
Date Cleared
2025-03-05
(261 days)
Product Code
GBM, EZD
Regulation Number
876.5130Why did this record match?
Applicant Name (Manufacturer) :
Well Lead Medical Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Hydrophilic Intermittent Catheter is used to empty the bladder for patients with urinary retention or incomplete bladder emptying.
Device Description
Hydrophilic intermittent catheter is a sterile, single use hollow tube inserted into the bladder to drain the urine at regular intervals. The catheter also contains a Polyvinyl Pyrrolidone hydrophilic-coating and is sterilized by irradiation. The product can be used on patients who need intermittent urine drainage. The Hydrophilic intermittent catheter is available for use in professional medical facilities and home environments.
The Hydrophilic Intermittent Catheter Ready to Use is placed in a wetting liquid, packed and sealed in a foil pouch and sterilized.
The Hydrophilic Intermittent Catheter Compact is placed in a wetting liquid inside the container, which together with screw cap, connector and plug make up the primary packaging and the sterile barrier.
The Hydrophilic Intermittent Catheter Ready to Use is available in three configurations:
- Ready to use Female (8Fr, 10Fr, 12Fr, 14Fr, 16Fr, 18Fr)
- Ready to use Standard (8Fr, 10Fr, 12Fr, 14Fr, 16Fr, 18Fr)
- Ready to use Tiemann (10Fr, 12Fr, 14Fr, 16Fr, 18Fr) .
The Hydrophilic Intermittent Catheter Compact is available in one configuration (8Fr, 10Fr, 12Fr, 14Fr, 16Fr, 16Fr).
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K Number
K220722Device Name
PVC Hydrophilic Urethral Catheter
Manufacturer
Well Lead Medical Co., Ltd.
Date Cleared
2023-05-22
(434 days)
Product Code
EZD
Regulation Number
876.5130Why did this record match?
Applicant Name (Manufacturer) :
Well Lead Medical Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Well Lead PVC Hydrophilic Urethral Catheter is launched for clean intermittent catheterization-CIC treatment and indicated for use by patients with chronic urine retention. The catheter is inserted into the urethra for emptying the bladder.
Device Description
The device is a urethral catheter used for intermittent catheterization. The device is a flexible single use urinary catheter inserted through the urethra to drain the bladder. The device is a disposable polyvinyl chloride (PVC) catheter coated with a hydrophilic coating (polyacrylamide) and an optional water sachet is included, which can activate the lubricant coating on the PVC. The device is generally for use in professional medical facilities and home environments. The catheters come in sizes from 6Fr – 22Fr for the Male Model, 6Fr – 22Fr for the Female Model and 10Fr – 22Fr for the Tiemann Model. The catheter can connect to two different shapes of connector (called connector I and connector II) provided with the device. The connector enables the catheter to be connected to a urine bag or other collection apparatus. Urine can also be drained directly into the toilet. The catheter is intended to be used for less than 24 hours based on the biocompatibility information provided. It is expected that patients will use a new intermittent catheter multiple times a day (each time urine needs to be drained).
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K Number
K220036Device Name
Wellead Ureteral Catheter
Manufacturer
Well Lead Medical Co., Ltd.
Date Cleared
2022-12-16
(345 days)
Product Code
KOD
Regulation Number
876.5130Why did this record match?
Applicant Name (Manufacturer) :
Well Lead Medical Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Ureteral Catheter is used for temporary urine drainage, delivery of irrigation fluids, injection of contrast agent to the urinary tract, navigation of a tortuous ureter, access, advancement or exchange of wire guides (open-ended catheters only).
Device Description
Ureteral Catheters are single-use and sterile devices, which consist of catheter, adapter and guide wire. Ureteral Catheters are available in a variety of French sizes and distal tip configurations. Ureteral Catheters have 5 different distal tip configurations, which are closed round tip, open tapered tip, open tip, open soft tip and open cone tip. The adapter and guide wire are optional and the choice of Ureteral Catheter, adapter and guide wire should be based on the physician's preference and clinical situation. The catheter tube is made of Polyvinylchloride (PVC). The catheter is uncoated. Recommend duration of use: less than 24 hours.
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K Number
K211543Device Name
Wei Nasal Jet Tube
Manufacturer
Well Lead Medical Co., LTD.
Date Cleared
2022-07-21
(428 days)
Product Code
BTR
Regulation Number
868.5730Why did this record match?
Applicant Name (Manufacturer) :
Well Lead Medical Co., LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
WEI nasal jet tube is indication for airway management, inserted through nasal cavity. During and after insertion, the Jet Tube can supply jet ventilation intermittently. When the Jet tube is not in use, the main tube serves as the main oxygen supply channel, and oxygen is supplied through main tube. The PetCO2 Monitor tube can connect to CO2 monitoring machine to monitor CO2 status.
Device Description
Wei Nasal Jet Tube is a sterile, single-use nasopharyngeal airway management, monitor PetCO2 and mechanical ventilation. Wei Nasal Jet Tube inserted into a patient's pharynx through the nose, it provides active, pulsatile and powerful supraglottic jet oxygenation and ventilation (SJOV) via a jet channel built into the wall of its distal end. It can be used to monitor PetCO2 via another channel built into the wall and open to the middle lumen of the tube. Wei Nasal Jet Tube can also augment oxygen supplies for patients with respiratory suppression or apnea during difficult airway managements.
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K Number
K211814Device Name
Wellead Endoscopic Seal
Manufacturer
Well Lead Medical CO., LTD.
Date Cleared
2022-01-14
(217 days)
Product Code
ODC
Regulation Number
876.1500Why did this record match?
Applicant Name (Manufacturer) :
Well Lead Medical CO., LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Endoscopic Seal is a self-sealing cap that is intended to prevent the backflow of fluid through the working channel of an endoscope.
Device Description
The Endoscopic Seal is mounted to the proximal port of the endoscope working channel and intended to resist the backflow of distention fluid when the channel is not being used or when instruments are passed through the working channel.
The Endoscopic Seal consists of a silicone seal, an introducer, and an adapter with sealing ring (optional). The Introducer is used to enable improved access during endoscopic procedures. The Adapter and Sealing Ringare optional for Endoscopic Seal. They are used with the non-standard Luer endoscopes.
The silicone seal combined with introducer can be used with all endoscopes with the proximal port of the working channel between 6 mm to 9 mm in its largest outside diameter. Mount the silicone seal onto the working channel of the Endoscope. Make sure the connection is tight. Insert the introducer into the silicone seal.If using the WOLF endoscope, mount the adapter with sealing ring onto the endoscope working channel port first and then place the silicone seal and introducer onto the adapter.
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K Number
K202134Device Name
Well Lead All Silicone Foley Catheter with Temperature Sensor
Manufacturer
Well Lead Medical Co., LTD.
Date Cleared
2021-04-08
(251 days)
Product Code
EZL
Regulation Number
876.5130Why did this record match?
Applicant Name (Manufacturer) :
Well Lead Medical Co., LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
All Silicone Foley Catheter With Temperature Sensor is intended for use in the drainage/collection of urine from the urinary bladder and simultaneous monitoring of the body core temperature during surgical intervals.
Device Description
The All Silicone Foley Catheter with Temperature Sensor is made from medical grade silicone, consists of temperature sensor for monitoring core body temperature and Foley catheter including a shaft, drainage funnel, inflation funnel, balloon, valve, and X-ray opaque line. The device is provided sterile by ethylene oxide and is for single use only. It is provided in a variety of sizes and color-coded by size.
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K Number
K203119Device Name
ClearPetra Suction-Evacuation Sheath
Manufacturer
Well Lead Medical Co., LTD.
Date Cleared
2020-12-09
(54 days)
Product Code
FED, FAJ, FGA
Regulation Number
876.1500Why did this record match?
Applicant Name (Manufacturer) :
Well Lead Medical Co., LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The ClearPetra Suction-Evacuation Sheath is used to establish a conduit during endoscopic urological procedures facilitating the passage of endoscopes and other instruments into the urinary tract. It is designed to establish a conduit for the treatment of urinary stones or other urinary diseases during endoscopic procedures.
Device Description
The ClearPetra Suction-Evacuation Sheath consists of a straight distal tube and a proximal bifurcated tube. The distal straight tube of the ureteral access sheath is reinforced with metal wires for torque resistance. One segment of the proximal bifurcated tube is straight and is contiguous with the distal tube. The other is constructed in an oblique angle with a longitudinal pressure control vent. An obturator is included for the insertion of the sheath. The obturator can be locked to the proximal end of the straight tube using a luer lock mechanism. A rubber cap with central aperture is included as an accessory. It is to be placed at the proximal end of the straight tube after the removal of the obturator. The oblique tube is to be connected directly to a negative pressure aspirator with a clear tube or alternatively, connected to a specimen collector (packed separately) then onto a negative pressure aspirator.
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K Number
K182739Device Name
Endotracheal Tube with Evacuation Lumen
Manufacturer
WELL LEAD MEDICAL CO., LTD.
Date Cleared
2019-12-11
(439 days)
Product Code
BTR
Regulation Number
868.5730Why did this record match?
Applicant Name (Manufacturer) :
WELL LEAD MEDICAL CO., LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Endotracheal Tube with Evacuation Lumen is intended for oral intubation and drainage of the subglottic space for airway management.
Device Description
The Endotracheal Tube with Evacuation Lumen is sterile, single-use devices supplied with a standard 15mm connector. The Endotracheal Tube with Evacuation Lumen is a Magill curved construction with primary lumen for patient ventilation. Two (2) narrower lumens within the primary wall are used for cuff inflation and subglottic evacuation (vacuum). A low pressure, conformable cuff is inflated through the inflation tube with pilot balloon using a standard syringe (air only) through a non-return valve. For evacuation of subglottic secretions, a separate suction line, with a capped connector, connects to standard hospital vacuum receptacles. The tube incorporates a radiopaque line to assist in radiographic visualization. The Endotracheal Tube with Evacuation Lumen is PVC (polyvinylchloride) tube with a cylindrical-shaped cuff. The cuff is available with two materials PVC (polyvinylchloride) and PU(polyurethane). It is available in sizes 6.0, 6.5, 7.0, 7.5, 8.0, 8.5 and 9.0mm and consists of tube, cuff, inflation tube, non-return valve, pilot balloon, 15mm connector, suction line.
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K Number
K160801Device Name
Well Lead Extraction Bag
Manufacturer
WELL LEAD MEDICAL CO., LTD.
Date Cleared
2016-11-29
(251 days)
Product Code
GCJ
Regulation Number
876.1500Why did this record match?
Applicant Name (Manufacturer) :
WELL LEAD MEDICAL CO., LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Well Lead Extraction Bag is intended for use by qualified surgeons in tissue extraction procedures during laparoscopic surgery.
Device Description
The Well Lead Extraction Bag is used for removal of tissue specimens during a suitable laparoscopic surgery.The device consists of a cylindrical sheath, a pusher and a polyurethane bag that minimizes spillage and intraoperative contamination by isolating and containing specimens. The bag is made of biocompatible high strength PU material, it is transparent and soft. which makes a qood visuality.
The device is composed of biologically safe materials. It is supplied sterile and intended for single use only. It's easy to enter, open, close and exit, higher efficiency, and different type and size available. It is offerd in 4 types: Type B, Type C, Type D and range in bag volume from 200ml for different surgery needs. The well thought-out rang of types and sizes are suitable for all laparoscopic procedures. The main differences between all types are the deployment system and operation method.
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K Number
K161110Device Name
ClearPetra Suction-Evacuation Sheath
Manufacturer
WELL LEAD MEDICAL CO., LTD.
Date Cleared
2016-10-12
(175 days)
Product Code
FED, FAJ, FGA
Regulation Number
876.1500Why did this record match?
Applicant Name (Manufacturer) :
WELL LEAD MEDICAL CO., LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The ClearPetra Suction-Evacuation Sheath is used to establish a conduit during endoscopic urological procedures facilitating the passage of endoscopes and other instruments into the urinary tract. It is designed to establish a conduit for the treatment of urinary stones or other urinary diseases during the endoscopic procedures.
Device Description
The ClearPetra Suction-Evacuation Sheath is designed to establish a conduit for the treatment of urinary stones or other urinary diseases during the endoscopic procedures. The intended use is for the passage of endoscopes and other urological devices for the purpose of performing diagnostic and surgical procedures such as, nephroscopy, ureteroscopy, or cystoscopy. It is used for the treatment of stones and for the removal of foreign bodies in the urinary tract.
The ClearPetra Suction-Evacuation Sheath comes in three models: ClearPetra Ureteral Access Sheath, ClearPetra Cystoscope Sheath and ClearPetra Nephrostomy Sheath. The Ureteral Access Sheath includes two versions: Access Sheath for the Semi-rigid Ureteroscope and Access Sheath for the Flexible Ureteroscope.
The ClearPetra Suction-Evacuation Sheath is comprised of the following components:
- Sheath
- Obturator
- Luer Connector
- Y Connector
- Rubber Cap
The sheath is fitted with a Y connector on the proximal end. The Y connector is bifurcated: straight tube and oblique tube, The distal straight tube of the ureteral access sheath is reinforced with metal wires for torque resistance.
one seqment of the Y connector is straight and is contiguous with the sheath: The other is constructed in an oblique angle with a longitudinal pressure control vent. The oblique tube is to be connected to a negative pressure aspirator with clear tube or alternatively, connected to a specimen collector then onto a negative pressure aspirator, then to collect stones or foreign bodies during the endoscopic procedure.
An obturator is included for the insertion of the sheath. The obturator is radiopaque and is fitted with a luer connector on the proximal end. The obturator can be locked to the proximal end of the straight tube using a luer lock mechanism. A rubber cap with central aperture is included as an accessory. It is to be placed at the proximal end of the straight tube after the removal of the obturator.
The device is offered in French size ranging from 10Fr to 22Fr and length 13cm to 55cm. The device is composed of biologically safe materials. It is supplied sterile and intended for single use only.
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