Data / Medical devices / United States / C2Dx, Inc.
C2Dx, Inc.: FDA-registered device maker in Schoolcraft, MI, United States, 9 510(k) clearances
C2Dx, Inc. is registered with the FDA (registration 3015489752) in Schoolcraft, MI, United States. It lists 7 device types. The FDA files 9 510(k) clearances under its listings, the newest dated October 24, 2023. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3015489752
- Address
- 555 E Eliza St Suite A, Schoolcraft, MI, United States, 49087
- Owner or operator
- Critical Care Diagnostics, Inc (10059775)
- Roles
- Complaint file establishment, Manufacturer, Specification developer
- First device listed
- February 21, 2019
- Registered through
- 2026
- Brand names listed
- 7013-5712 MODEL 5712 BLADE (QTY 24) FOR MODEL 600D, 2400Z, AND P8400 THERMAL SCALPEL SYSTEM CONTROLLERS; 7023-5712 MODEL, 7013-5810 - Hemostatix Thermal System #10 Blade - Qty 24; 7013-5815 - Hemostatix Thermal Scalpel System #15 Blade - QTY, 7013-8050 HANDLE FOR MODEL P8400 HEMOSTATIX THERMAL SCALPEL SYSTEM CONTROLLER; 7013-8400 MODEL P8400 HEMOSTATIX THERMAL, Advance® Salivary Balloon Catheter with Wire Guide, Fixed Core Wire Guide, Kolenda Salivary Access Introducer Set, Mul T Blanket, Mul T Pad and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Catheter, Drainage, Intraoral/Extraoral | OAJ | 1 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Dilator, Catheter | GCC | 1 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Electrosurgical, Cutting & Coagulation & Accessories | GEI | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Laparoscope, General & Plastic Surgery | GCJ | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Monitor, Pressure, Intracompartmental | LXC | U | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Pack, Hot Or Cold, Water Circulating | ILO | 2 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Wire, Guide, Catheter | DQX | 2 | Complaint file establishment, Manufacturer | 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 |
|---|---|---|---|---|---|---|
| October 24, 2023 | K233185 | MODEL P8400 Controller for C2DXs Hemostatix Thermal Scalpel System | GEI | Substantially Equivalent | C2dx, Inc. | accessdata.fda.gov |
| November 26, 2018 | K183009 | HEMOSTATIX MODEL P8400 DISPOSABLE HANDLE, HEMOSTATIX MODEL P8400 DISPOSABLE BLADES | GEI | Substantially Equivalent | Hemostatix Medical Technologies, LLC | accessdata.fda.gov |
| March 9, 2018 | K171764 | Fixed Core Wire Guides | DQX | Substantially Equivalent | Cook Incorporated | accessdata.fda.gov |
| December 15, 2014 | K140593 | ADVANCE SALIVARY BALLOON CATHETER WITH WIRE GUIDE | GCJ | Substantially Equivalent | Cook, Inc. | accessdata.fda.gov |
| July 6, 2012 | K120468 | NCIRCLE(R) NITINOL TIPLESS STONE EXTRACTOR NGAGE(R) NITINOL STONE EXTRACTOR | GCJ | Substantially Equivalent | Cook Incorporated | accessdata.fda.gov |
| May 1, 2009 | K091107 | MODEL P8400 HEMOSTATIX THERMAL SCALPEL SYSTEM | GEI | Substantially Equivalent | Hemostatix Medical Technologies, LLC | accessdata.fda.gov |
| May 8, 2008 | K073675 | T-PUMP LOCALIZED TEMPERATURE THERAPY PUMP | ILO | Substantially Equivalent | Gaymar Industries, Inc. | accessdata.fda.gov |
| August 24, 2000 | K002021 | HEMOSTATIX THERMAL SCALPEL SYSTEM - #12 BLADE | GEI | Substantially Equivalent | Gyrus Ent LLC | accessdata.fda.gov |
| April 4, 1985 | K844214 | COMPARTMENT SYNDROME PRESSURE MONITOR SYS | LXC | Substantially Equivalent | Stryker Corp. | accessdata.fda.gov |
Compare with other makers
- All makers of Electrosurgical, Cutting & Coagulation & Accessories
- All makers of Monitor, Pressure, Intracompartmental
- All makers of Catheter, Drainage, Intraoral/Extraoral
- All makers of Dilator, Catheter
- All makers of Laparoscope, General & Plastic Surgery
- All makers of Pack, Hot Or Cold, Water Circulating
Updated October 24, 2023. 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.