Mederi Therapeutics, Inc.
United StatesFDA applicant, unverified
- Devices
- 2
- FDA recalls
- 1
At a glance
Market reach
- United States
- FDA recalls
What Mederi Therapeutics, Inc. makes
Mederi Therapeutics, Inc. produces reusable monopolar endoscopic electrosurgical handpieces and electrodes, including systems for controlled tissue ablation and catheter-based radiofrequency treatments. Their portfolio includes devices like the Secca system for endoscopic mucosal resection and the Stretta catheter for gastrointestinal tissue modification. The company also supplies a dedicated RF generator control module for these procedures.
The company’s devices are classified as Class II under FDA regulations and are listed in the FDA’s 510(k) and Unique Device Identifier (UDI) databases. These products are intended for use in specialized endoscopic and radiofrequency-based medical procedures. The manufacturer is based in the United States.
Catalogue
Mederi Therapeutics Rf Generator Control Module Ref K103017
Regimes: 510(k) Registry: 510(k)Stretta Catheter Ref K152317
Regimes: 510(k) Registry: 510(k)
Company details
- DUNS number
- 022785895
- [email protected]
- Phone
- 2039309980
FDA recalls
FDA recall records list 1 recall initiated by Mederi Therapeutics, Inc., initiated on 2017-04-03. By recorded status: 1 terminated. The reasons filed fall into these groups: sterility or contamination and packaging. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.
Recalls initiated per year
- 2017 1
- 2018 0
- 2019 0
- 2020 0
- 2021 0
- 2022 0
- 2023 0
- 2024 0
- 2025 0
- 2026 0
2017
- 3 Apr 2017 Z-2050-2017 Class II Terminated Product sterility compromised due to breach in sterile barrier package
Full distribution text
- 3 Apr 2017 Z-2050-2017 Class II Terminated Product sterility compromised due to breach in sterile barrier package
Frequently asked questions
How many devices does Mederi Therapeutics, Inc. have in the registry?
The registry currently lists 2 devices for Mederi Therapeutics, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Mederi Therapeutics, Inc.'s devices?
Among its 2 most recently registered devices, Mederi Therapeutics, Inc. has devices listed in FDA 510(k) (2 devices).
What risk classes do Mederi Therapeutics, Inc.'s devices fall under?
Among its 2 most recently registered devices, the classes recorded for Mederi Therapeutics, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for Mederi Therapeutics, Inc.?
FDA recall records list 1 recall initiated by Mederi Therapeutics, Inc., the most recent initiated on 3 Apr 2017. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.
What are the newest devices from Mederi Therapeutics, Inc. in the registry?
The most recently registered devices listed for Mederi Therapeutics, Inc. include MEDERI THERAPEUTICS RF GENERATOR CONTROL MODULE and Stretta Catheter.