Data / Medical devices / United States / Icp, Inc.
Icp, Inc.: FDA-registered device maker in Green Bay, WI, United States, 2 510(k) clearances
Icp, Inc. is registered with the FDA (registration 2132509) in Green Bay, WI, United States. It lists 6 device types. The FDA files 2 510(k) clearances under its listings, the newest dated May 11, 2017. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 2132509
- FEI number
- 1000220974
- Address
- 3205 Yeager Dr, Green Bay, WI, United States, 54311
- Owner or operator
- ICP, INC. (9009593)
- Roles
- Specification developer
- First device listed
- March 23, 2026
- Registered through
- 2026
- Brand names listed
- Guardian
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Band, Elastic, Orthodontic | ECI | 1 | Specification developer | accessdata.fda.gov |
| Bur, Dental | EJL | 1 | Specification developer | accessdata.fda.gov |
| Indicator, Physical/Chemical Sterilization Process | JOJ | 2 | Specification developer | accessdata.fda.gov |
| Latex Patient Examination Glove | LYY | 1 | Specification developer | accessdata.fda.gov |
| Mouthpiece, Saliva Ejector | DYN | 1 | Specification developer | accessdata.fda.gov |
| Wrap, Sterilization | FRG | 2 | Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| May 11, 2017 | K161961 | UniTex Non-Sterile, Powder-Free, Latex Examination Glove | LYY | Substantially Equivalent | Ug Global Resources Sdn. Bhd. | accessdata.fda.gov |
| April 28, 2017 | K162258 | Self Sealing Sterilization Pouches | FRG | Substantially Equivalent | Tianchang Jiarui Packaging Material Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Mouthpiece, Saliva Ejector
- All makers of Latex Patient Examination Glove
- All makers of Bur, Dental
- All makers of Indicator, Physical/Chemical Sterilization Process
- All makers of Wrap, Sterilization
- All makers of Band, Elastic, Orthodontic
Updated May 11, 2017. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.