Product code OVY— General Hospital

“The liquid chemical processing system is intended as a standard method for routine monitoring.”

FDA has cleared 4 devices under product code OVY between 2012 and 2023, filed by 1 applicant company. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

• 20232 clearances
• 20181 clearance
• 20121 clearance

• STERIS Corporation4 clearances

• K233682 — VERIFY SPORE TEST STRIP for S40 STERILANT CONCENTRATESTERIS Corporation·2023-12-15
• K231746 — VERIFY Spore Test Strip for S40 Sterilant ConcentrateSTERIS Corporation·2023-09-11
• K180553 — VERIFY Spore Test Strip for S40 SterilantSTERIS Corporation·2018-05-29
• DEN110002 — SYSTEM 1E PROCESS BIOLOGICAL MONITORING KITSTERIS Corporation·2012-03-30