・ Cranial pressure transducer cables

・ Cryoprobes

・ Defibrillator paddles

・ Dopplers

・ Electrocautery instruments

・ Endoscopic instruments

・ Esophageal dilators

・ Fiberoptic lite cables

・ Laryngoscope blads

・ Laser handpieces, fibers, and accessories

・ Metal instruments

・ Ophthalmic lenses (diagnostic, magnifying)

・ Patient lead cables

・ Pigmentation handpieces

・ Radiation therapy equipment

・ Resectoscope / working elements and sheaths

・ Rigid endoscopes

・ Shaver handpieces

・ Flexible endoscopes

・ Stereotactic equipment and batteries

・ Trocar sheaths

・ Ultrasound probes

・ Video cameras and couplers

・ Micro instrument kit

・ Laparoscopic Grasping Forceps

・ Bipolar Forceps with cables

・ Vessel Sealer

・ Electrosurgical Pencils

・ Endotracheal Tube

・ Surgical Staples

・ Micro Instrument Set

・ Oxygen tubing

・ Suction & Irrigation tube

・ Oxygen mask

・ Surgical tips

・ Catheters

・ Biopsy forceps

Visit our user manual page or navigate to our instructional video page to learn more.

- User Manuals

- Instructional Videos

There are two devices: 

• STERLINK Plus: 05/25/2023 
• STERLINK mini: 04/14/2023 

The link to the FDA website is: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm

• Once in the site, go to Applicant Name and type in: Plasmapp
• Here you will find quite a bit of information about the 510k

• The Animal Health Market version of the Low-Temperature Plasma Sterilizers have been selling in the US since 2021.  Over this time, the devices have been pressure tested and improved within the Animal Health space and the technology and learnings were engineered into the Human Health Market devices. 
• The devices are currently sold in over 50 countries, this is their entry into the US market.

• As of now, Plasmapp does not have a larger version of the device.  The STERLINK has a 14-liter chamber, approximately 3.7 gallons.
• As demand grows and our customers see value in a larger plasma sterilizer, we will look to enhance our portfolio to match that specific demand.

• Please refer to the Medical Device Compatibility List on our website. If you are not able to find the information that you are looking for, please let us know the product information, manufacturer, product name, and model number, then our validation team can verify if they are compatible.

• Yes, the same classification product code is MLR. 

• The STERLINK sterilizer can be operated in 2 modes: Pouch Mode and Chamber Mode.
• Pouch Mode uses a consumable called the STERPACK plus and runs a 14-minute sterilization cycle. 
• In Pouch Mode, the needle penetrates a silicone nipple at the top of the STERPACK plus.  The hydrogen peroxide in the cartridge is released into the pouch due to the differential pressure and causes a vacuuming effect of the pouch.  Once the medical device is sterilized it will remain sterile in the sealed pouch for up to 6 months.

• Chamber Mode uses a consumable called the STERLOAD and runs a 36-minute sterilization cycle. In this mode, the entire chamber is used, and no pouch is needed.

• The STERLINK’s chamber operates at 130F and is regulated by several redundant temperature sensors within the walls of the chamber and does not harm instruments like the vacuum steam sterilizers.  The 130F operating temperature is not for killing bacteria but rather to dry any moisture in the chamber.  If excessive moisture is detected by the Plasmapp detection system, the unit will stop with a precautionary message to dry out the tools prior to sterilization.  Consider the low heat like a blow dryer.  

• Yes, there are residual purchases from consumable products used in the sterilizer.

• A ventilation system is not required for the Plasmapp STERILINK sterilization system. Steam and oxygen are the only by-products from the STERLINK, both released through the side of the sterilizer as shown below; eco-friendly, and pretty cool.  No need for ventilation of harmful ETO gases, or tubes for discharge of wastewater from a typical steam sterilizer autoclave. The red circled area is where steam and oxygen are released.