510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K122658Substantially Equivalent

Femcerv Endocervical Sampler Model 3 Sizes: Ref Fcv-013, Ref Fcv-011, Ref Fcv-009

Femasys Inc., Suwanee GA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K122658 is the FDA 510(k) clearance record for FEMCERV ENDOCERVICAL SAMPLER MODEL 3 SIZES: REF FCV-013, REF FCV-011, REF FCV-009, a class II device, cleared for Femasys, Inc. on under FDA product code PCF (Sampler, Endocervical). FDA's definition for product code PCF reads: "Obtains tissue samples from the endocervical canal for histological analysis". FDA records list 9 510(k) clearances for Femasys, Inc., from to . As of , FDA records show no recalls naming K122658.

Clearance record

Decision date
Received
(111 days to decision)
Product code
PCF Sampler, Endocervical
Regulation
21 CFR 884.1050
Device class
Class II
Review panel
Obstetrics/Gynecology
Applicant
Femasys, Inc. 5000 Research Ct., Suite 100, Suwanee GA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code PCF

Trailing 12 months

FDA records hold no clearances under product code PCF in the trailing twelve months.

FDA records show no clearances under product code PCF in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code PCF, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260