FDA applicant
Suretex Prophylactics, Ltd.
FDA records 1 decision for Suretex Prophylactics, Ltd. (Dothan, AL) in 2000: 1 510(k) clearance. All are in product code HIS (Condom). 2 recalls are linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Suretex Prophylactics, Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for Suretex Prophylactics, Ltd. since 2007.
Recalls per year
1in 2012
Class I Class II/III not classified
Planning a device like Suretex Prophylactics, Ltd.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.
See the 510(k) ReportOther applicant names beginning “Suretex”
FDA records each applicant name separately; these may or may not be the same firm.