FEMCERV ENDOCERVICAL SAMPLER MODEL 3 SIZES: REF FCV-013, REF FCV-011, REF FCV-009

Sampler, Endocervical

FEMASYS INC.

The following data is part of a premarket notification filed by Femasys Inc. with the FDA for Femcerv Endocervical Sampler Model 3 Sizes: Ref Fcv-013, Ref Fcv-011, Ref Fcv-009.

Pre-market Notification Details

• Device ID: K122658
• 510k Number: K122658
• Device Name: FEMCERV ENDOCERVICAL SAMPLER MODEL 3 SIZES: REF FCV-013, REF FCV-011, REF FCV-009
• Classification: Sampler, Endocervical
• Applicant: FEMASYS INC. 5000 Research Court Suite 100 Suwanee, GA 30024
• Contact: Lisa Peacock
• Correspondent: Lisa Peacock; FEMASYS INC. 5000 Research Court Suite 100 Suwanee, GA 30024
• Product Code: PCF
• CFR Regulation Number: 884.1050 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2012-08-31
• Decision Date: 2012-12-20
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00859500005066	K122658	000
00859500005059	K122658	000
10859500005063	K122658	000
10859500005056	K122658	000