Femecc Endocervical Curette

FDA 510(k) K060320 · Femspec LLC

Substantially Equivalent

510(k) numberK060320

Submission

Device name
Femecc Endocervical Curette
Applicant
Femspec LLC
Port Townsend, WA, US
Received
February 8, 2006
Decision date
July 28, 2006
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
PCF – Sampler, Endocervical
Device class
Class II (moderate risk)
Regulation
21 CFR 884.1050
Specialty
Obstetrics/Gynecology

Obtains tissue samples from the endocervical canal for histological analysis.

Other 510(k)s with product code PCF

510(k)DeviceApplicantDecision
K122658Femcerv Endocervical Sampler Model 3 Sizes: Ref FCV-013, Ref FCV-011, Ref FCV-009PCF · Traditional Femasys, Inc.12/20/2012SE
K882606Euro-Med Endo-CurettePCF · Traditional Buckman Co., Inc.07/25/1988SE
K882404Kevor-CurettePCF · Traditional Euro-Med Intl.07/08/1988SE
K860796Dispo-UrettePCF · Traditional Roland J. Zwick, Inc.04/08/1986SE

More from Roland J. Zwick, Inc.

510(k)DeviceDecision
K052192Femspce-S Disposable Sterile Vaginal Speculum, Model St-IHIB · Traditional 02/02/2006SE
K051294Femtest Endometrial Suction Curette, Model FT-1HHK · Traditional 12/21/2005SE
K041757Femspec Disposable Vaginal SpeculumHIB · Traditional 12/23/2004SE

Questions and answers

When was Femecc Endocervical Curette cleared by the FDA?

Femecc Endocervical Curette (K060320) received a 510(k) decision of Substantially Equivalent on July 28, 2006, 170 days after the submission was received.

What is the product code of K060320?

The FDA product code is PCF – Sampler, Endocervical, a Class II (moderate risk) device regulated under 21 CFR 884.1050.