510(k) K122658

FEMCERV ENDOCERVICAL SAMPLER MODEL 3 SIZES: REF FCV-013, REF FCV-011, REF FCV-009 by Femasys, Inc. — Product Code PCF

K122658 is an FDA 510(k) premarket notification submitted by Femasys, Inc. for the device "FEMCERV ENDOCERVICAL SAMPLER MODEL 3 SIZES: REF FCV-013, REF FCV-011, REF FCV-009". The FDA issued a decision of Substantially Equivalent on December 20, 2012. The device falls under product code PCF (Sampler, Endocervical), a Class II device regulated under 21 CFR 884.1050. Femasys, Inc. has at least 8 other 510(k) clearances on record.