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

Sampler, Endocervical

21 CFR 884.1050 / Obstetrics/Gynecology
FDA source (opens on fda.gov)

PCF is the FDA product code for Sampler, Endocervical, a class II device type, regulated under 21 CFR 884.1050. FDA's definition for this code reads: "Obtains tissue samples from the endocervical canal for histological analysis". As of , FDA records hold 5 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
PCF
Device name
Sampler, Endocervical
FDA definition
Obtains tissue samples from the endocervical canal for histological analysis.
Regulation
21 CFR 884.1050
Device class
Class II
Review panel
Obstetrics/Gynecology
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
Yes
Ingested clearances
5
Ingested recalls
0

Clearances, product code PCF

By decision year
5 clearances under product code PCF with a decision year between 1986 and 2012, 1988 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code PCF by decision year
YearClearances
19861
19882
20061
20121

Applicants with the most clearances

Product code PCF
Applicants holding the most 510(k) clearances under product code PCF
ApplicantClearances
Buckman Co., Inc.1
Euro-Med Intl.1
Femasys Inc.1
Femspec LLC1
Roland J. Zwick, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code