Data / Medical devices / India / Virchow Biotech Pvt. Ltd.
Virchow Biotech Pvt. Ltd.: FDA-registered device maker in Hyderabad Telangana, India, 10 510(k) clearances
Virchow Biotech Pvt. Ltd. is registered with the FDA (registration 3010315629) in Hyderabad Telangana, India. It lists 2 device types. The FDA files 10 510(k) clearances under its listings, the newest dated April 27, 2018. Registered through 2026. FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- FDA registration number
- 3010315629
- Address
- Survey No. 172 (Part) Gagillapur, Dundigal, Medchal-Malkajgiri District, Hyderabad Telangana, India, 500043
- Owner or operator
- Virchow Biotech Private Limited (10054022)
- Roles
- Manufacturer, Specification developer
- First device listed
- February 2, 2017
- Registered through
- 2026
- Brand names listed
- AcryDerm Silver Antimicrobial Dressing B, AcryDerm Silver Antimicrobial Foam Dressing, AcryDerm Silver Antimicrobial Gauze Dressing, High Concentration Silver Gel, Ionsil Gel, SilvaSorb Antimicrobial Wound Gel, SilvaSorb Dressing, SilvaSorb Perforated Dressing and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic | MGQ | U | Manufacturer | accessdata.fda.gov |
| Dressing, Wound, Drug | FRO | U | Manufacturer, 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 |
|---|---|---|---|---|---|---|
| April 27, 2018 | K172747 | HYALURONIC ACID TOPICAL WOUND CREAM | FRO | Substantially Equivalent | Virchow Biotech Pvt, Ltd. | accessdata.fda.gov |
| August 21, 2014 | K132326 | IONSIL GEL | FRO | Substantially Equivalent | Virchow Biotech Pvt, Ltd. | accessdata.fda.gov |
| October 21, 2009 | K091354 | ACRYDERM SILVER ANTIMICROBIAL FOAM WOUND DRESSING | FRO | Substantially Equivalent | Acrymed, Inc. | accessdata.fda.gov |
| February 26, 2009 | K083103 | ACRYDERM ANTIMICROBIAL SILVER GEL WOUND DRESSING MODEL #B | FRO | Substantially Equivalent | Acrymed, Inc. | accessdata.fda.gov |
| July 10, 2007 | K070333 | ACRYDERM SILVER ANTIMICROBIAL OTC WOUND GEL | FRO | Substantially Equivalent | Acrymed, Inc. | accessdata.fda.gov |
| October 6, 2006 | K061232 | ACRYDERM SILVER ANTIMICROBIAL THIN FILM, MODEL 2006 | FRO | Substantially Equivalent | Acrymed, Inc. | accessdata.fda.gov |
| June 9, 2005 | K042164 | SILVER ANTIMICROBIAL WOUND GAUZE (SPONGE) | FRO | Substantially Equivalent | Medline Industries, Inc. | accessdata.fda.gov |
| November 8, 2001 | K011994 | ACRYDERM SILVER ANTTIMICROBIAL WOUND GEL MODEL# A-002101 | MGQ | Substantially Equivalent | Acrymed, Inc. | accessdata.fda.gov |
| September 12, 2001 | K012116 | ACRYDERM SILVER ANTIMICROBIAL PERFORATED WOUND DRESSING | FRO | Substantially Equivalent | Acrymed, Inc. | accessdata.fda.gov |
| September 21, 2000 | K002599 | MODIFICATION TO ACRYDERM SILVER ANTIMICROBIAL WOUND DRESSING, MODELS 1041, 1042, 1043, 1044, 1045 | FRO | Substantially Equivalent | Acrymed, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Dressing, Wound, Drug
- All makers of Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic
Updated April 27, 2018. 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.