Atlas FDA

PCF

5 FDA 510(k) clearances · Product code

35 daysmedian time to decision
170 days90th percentile
5clearances measured

FDA profile

Official device name
Sampler, Endocervical
Device class
Class II (moderate risk)
Regulation
21 CFR 884.1050
Medical specialty
Obstetrics/Gynecology
Flags
Third-party review eligible
FDA definition
Obtains tissue samples from the endocervical canal for histological analysis.
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RecordFirmDate
FEMCERV ENDOCERVICAL SAMPLER MODEL 3 SIZES: REF FCV-013, REF FCV-011, REF FCV-009 (K122658)Femasys, Inc.2012-12-20
FEMECC ENDOCERVICAL CURETTE (K060320)Femspec LLC2006-07-28
EURO-MED ENDO-CURETTE (K882606)Buckman Co., Inc.1988-07-25
KEVOR-CURETTE (K882404)Euro-Med Intl.1988-07-08
DISPO-URETTE (K860796)Roland J. Zwick, Inc.1986-04-08

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Every clearance here is in the API, with alerts when new ones post.