510(k) K012277

PORTEX RING PESSARY PVC-NON STERILE; PORTEX RING PESSARY POLYTHENE- NON STERILE by Sims Portex , Ltd. — Product Code HHW

K012277 is an FDA 510(k) premarket notification submitted by Sims Portex , Ltd. for the device "PORTEX RING PESSARY PVC-NON STERILE; PORTEX RING PESSARY POLYTHENE- NON STERILE". The FDA issued a decision of Substantially Equivalent on February 11, 2002. The device falls under product code HHW (Pessary, Vaginal), a Class II device regulated under 21 CFR 884.3575. Sims Portex , Ltd. has at least 10 other 510(k) clearances on record.