Search Results
Found 3 results
510(k) Data Aggregation
K Number
K030838Device Name
WARTNER PRO
Manufacturer
WARTNER MEDICAL PRODUCTS
Date Cleared
2003-06-27
(102 days)
Product Code
GEH
Regulation Number
878.4350Why did this record match?
Applicant Name (Manufacturer) :
WARTNER MEDICAL PRODUCTS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
WARTNER PRO® is intended for the treatment of common warts and plantar warts in adults and children over the age of 4. Common warts are recognized by the rough 'cauliflower-like' appearance ci the surface. The plantar wart is recognized by its location only on the bottom of the foot, its tenderness, and the interruption of the footprint pattern. The product is intended as an OTC device, which will be marketed to professionals, allied professionals, and semi-professionals.
Device Description
WARTNER PRO® is a cryosurgical system for the treatment of warts. It consists of
- A canister filled with 125 ml of a liquid mixture of the compressed gases . dimethyl ether and propane. This gas mixture does not harm the ozone layer, and has a four-year shelf life.
- 42 Foam applicators in three different sizes (6 mm, 7 mm, 8 mm) .
- An applicator stick/key for holding a foam applicator which is required to . dispense the liquid to the applicator, and is held by the person during treatment
- . Information booklet
The pressurized canister is filled with dimethyl ether and propane, which acts as a cryogen. The key is fitted with a foam applicator, which is inserted into the safety valve opening in the canister. The valve releasing the cryogen can only be actuated when the key is in place and depressed. When the key is depressed it saturates the foam applicator with the cold cryogenic gases and lowers the temperature of the applicator to approximately -50℃. The foam applicator is then placed on the wart. The freezing kills the wart and the infected skin causing the wart to fall off within a few days.
Ask a Question
K Number
K011708Device Name
MODIFICATION TO WARTNER WART REMOVAL SYSTEM
Manufacturer
WARTNER MEDICAL PRODUCTS
Date Cleared
2002-02-20
(261 days)
Product Code
GEH
Regulation Number
878.4350Why did this record match?
Applicant Name (Manufacturer) :
WARTNER MEDICAL PRODUCTS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Wartner Wart Removal System is intended for the over-the-counter treatment of common warts.
Device Description
Wartner Wart Removal System is a cryosurgical system for the treatment of warts. It consists of
- A canister filled with 35 ml of a liquid mixture of the compressed gases . dimethyl ether and propane. This gas mixture does not harm the ozone layer, and has a four-year shelf life.
- . Ten foam applicators
- . An applicator stick/key for holding a foam applicator, required to dispense the liquid to the applicator, and held by the person during treatment
- An illustrated description of how to use the product .
Ask a Question
K Number
K002714Device Name
WARTNER WART REMOVAL SYSTEM
Manufacturer
WARTNER MEDICAL PRODUCTS
Date Cleared
2000-11-28
(89 days)
Product Code
GEH
Regulation Number
878.4350Why did this record match?
Applicant Name (Manufacturer) :
WARTNER MEDICAL PRODUCTS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
Ask a Question
Page 1 of 1