Data / Medical devices / United States / Surgical Health Solutions, Inc
Surgical Health Solutions, Inc: FDA-registered device maker in Dripping Springs, TX, United States, 2 510(k) clearances
Surgical Health Solutions, Inc is registered with the FDA (registration 3043622938) in Dripping Springs, TX, United States. It lists 2 device types. The FDA files 2 510(k) clearances under its listings, the newest dated May 31, 2024. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 3043622938
- Address
- 177 Townes Ct, Dripping Springs, TX, United States, 78620
- Owner or operator
- Surgical Health Solutions, Inc (10095166)
- Roles
- Repackager or relabeler
- First device listed
- February 1, 2026
- Registered through
- 2026
- Brand names listed
- SurgiHEAL PRO Antimicrobial Hydrogel Spray, SurgiHEAL PRO Wound Cleansing and Irrigation Formula
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Dressing, Wound, Drug | FRO | U | Repackager or relabeler | accessdata.fda.gov |
| Lavage, Jet | FQH | 2 | Repackager or relabeler | 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 31, 2024 | K232080 | Puracyn® Plus Antimicrobial Irrigation Solution | FRO | Substantially Equivalent | Innovacyn, Inc. | accessdata.fda.gov |
| November 19, 2015 | K150799 | Puracyn(R) Plus Duo-Care(TM) Antimicrobial Wound & Skin Hydrogel, Puracyn(R) Plus Antimicrobial Hydrogel Professional Formula | FRO | Substantially Equivalent | Innovacyn, Inc. | accessdata.fda.gov |
Compare with other makers
Updated May 31, 2024. 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.