Data / Medical devices / United States / Sooka Inc.
Sooka Inc.: FDA-registered device maker in Boca Raton, FL, United States, 4 510(k) clearances
Sooka Inc. is registered with the FDA (registration 3007671445) in Boca Raton, FL, United States. It lists 1 device type. The FDA files 4 510(k) clearances under its listings, the newest dated February 21, 2006. 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
- 3007671445
- Address
- 102 NE 2nd Street Ste 137, Boca Raton, FL, United States, 33432
- Owner or operator
- Sooka Inc. (10033614)
- Roles
- Repackager or relabeler
- First device listed
- September 3, 2010
- Registered through
- 2026
- Brand names listed
- GLYDE, GLYDE Condom
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Condom | HIS | 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 |
|---|---|---|---|---|---|---|
| February 21, 2006 | K053367 | MALE NATURAL RUBBER LATEX CONDOM | HIS | Substantially Equivalent | Innolatex Sdn. Bhd | accessdata.fda.gov |
| September 24, 2004 | K041837 | INNOLATEX MALE LATEX CONDOMS COLORED AND SCENTED | HIS | Substantially Equivalent | Innolatex Sdn. Bhd | accessdata.fda.gov |
| November 9, 2001 | K012964 | 56MM CONDOM,MALE NATURAL RUBBER LATEX CONDOM | HIS | Substantially Equivalent | Innolatex Sdn. Bhd | accessdata.fda.gov |
| December 19, 2000 | K002393 | NON-SPERMICIDAL LUBRICATED MALE LATEX CONDOM | HIS | Substantially Equivalent | Innolatex Sdn. Bhd | accessdata.fda.gov |
Compare with other makers
Updated February 21, 2006. 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.