Data / Medical devices / United States / Rochal Technologies LLC
Rochal Technologies LLC: FDA-registered device maker in San Antonio, TX, United States, 10 510(k) clearances
Rochal Technologies LLC is registered with the FDA (registration 3021784063) in San Antonio, TX, United States. It lists 4 device types. The FDA files 10 510(k) clearances under its listings, the newest dated March 30, 2023. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3021784063
- Address
- 12000 Network Blvd Suite B200, San Antonio, TX, United States, 78249
- Owner or operator
- Rochal Technologies LLC (10083087)
- Roles
- Specification developer
- First device listed
- October 25, 2021
- Registered through
- 2026
- Brand names listed
- Antimicrobial Barrier Film Dressing, BIAKOS Antimicrobial Skin & Wound Cleanser, BIAKOS Antimicrobial Skin & Wound Irrigation Solution, BIAKOS Antimicrobial Wound Gel, BIASURGE Advanced Surgical Solution, CellerateRX, Hycol, Hycure Oral / Hycure Oral Smart Gel and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Bandage, Liquid | KMF | 1 | Specification developer | accessdata.fda.gov |
| Dressing, Wound, Drug | FRO | U | Specification developer | accessdata.fda.gov |
| Lavage, Jet | FQH | 2 | Specification developer | accessdata.fda.gov |
| Wound Dressing With Animal-Derived Material(S) | KGN | U | 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 |
|---|---|---|---|---|---|---|
| March 30, 2023 | K223377 | BIASURGE Advanced Surgical Solution | FRO | Substantially Equivalent | Rochal Technologies, LLC | accessdata.fda.gov |
| February 7, 2020 | K192527 | Rochal Antimicrobial Wound Gel | FRO | Substantially Equivalent | Rochal Industries, LLC | accessdata.fda.gov |
| September 30, 2016 | K161212 | Atteris Antimicrobial Skin Protectant | FRO | Substantially Equivalent | Rochal Industries, LLC | accessdata.fda.gov |
| July 28, 2016 | K160192 | Atteris Antimicrobial Skin & Wound Cleanser | FRO | Substantially Equivalent | Rochal Industries, LLC | accessdata.fda.gov |
| July 26, 2016 | K160684 | Atteris No-Sting Skin Protectant | KMF | Substantially Equivalent | Rochal Industries, LLC | accessdata.fda.gov |
| June 19, 2014 | K132891 | HYDROLYZED COLLAGEN/AG WOUND GEL WITH SILVER | FRO | Substantially Equivalent | The Hymed Group Corp. | accessdata.fda.gov |
| October 30, 2008 | K081724 | HYDROLYZED COLLAGEN WITH 10% CHONDROITIN SULFATE (PSGAG, POLYSULFATED GLYCOSAMINOGLYCAN) WOUND GEL | KGN | Substantially Equivalent | Applied Nutritionals | accessdata.fda.gov |
| December 20, 2006 | K061227 | HYDROLYZED COLLAGEN/AG WOUND GEL WITH SILVER | FRO | Substantially Equivalent | The Hymed Group Corp. | accessdata.fda.gov |
| March 22, 2000 | K994339 | HYCURE ORAL / HYCURE ORAL SMART GEL | KGN | Substantially Equivalent | The Hymed Group Corp. | accessdata.fda.gov |
| January 17, 1996 | K955506 | HYCURE | KGN | Substantially Equivalent | The Hymed Group Corp. | accessdata.fda.gov |
Compare with other makers
- All makers of Dressing, Wound, Drug
- All makers of Wound Dressing With Animal-Derived Material(S)
- All makers of Lavage, Jet
- All makers of Bandage, Liquid
Updated March 30, 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.