Product code PCF— Obstetrics/Gynecology

DISPO-URETTE

Classification name: Sampler, Endocervical
Device class: Class 2
Regulation: 21 CFR 884.1050
Advisory panel: Obstetrics/Gynecology
Total cleared: 5
First cleared: 1986-04-08
Most recent: 2012-12-20

FDA classification definition

“Obtains tissue samples from the endocervical canal for histological analysis.”
— U.S. Food and Drug Administration, device classification record for product code PCF under 21 CFR 884.1050, via openFDA

Market context for product code PCF

FDA has cleared 5 devices under product code PCF between 1986 and 2012, filed by 5 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

20121 clearance
20061 clearance
19882 clearances
19861 clearance

Top applicants under product code PCF

Roland J. Zwick, Inc.1 clearance
Femspec LLC1 clearance
Femasys, Inc.1 clearance
Euro-Med Intl.1 clearance
Buckman Co., Inc.1 clearance

Recent clearances under product code PCF

K122658 — FEMCERV ENDOCERVICAL SAMPLER MODEL 3 SIZES: REF FCV-013, REF FCV-011, REF FCV-009Femasys, Inc.·2012-12-20
K060320 — FEMECC ENDOCERVICAL CURETTEFemspec LLC·2006-07-28
K882606 — EURO-MED ENDO-CURETTEBuckman Co., Inc.·1988-07-25
K882404 — KEVOR-CURETTEEuro-Med Intl.·1988-07-08
K860796 — DISPO-URETTERoland J. Zwick, Inc.·1986-04-08

Data sourced from openFDA. This site is unofficial and independent of the FDA.