Femcerv Endocervical Sampler Model 3 Sizes: Ref FCV-013, Ref FCV-011, Ref FCV-009
FDA 510(k) K122658 · Femasys, Inc.
510(k) numberK122658
Submission
- Device name
- Femcerv Endocervical Sampler Model 3 Sizes: Ref FCV-013, Ref FCV-011, Ref FCV-009
- Applicant
- Femasys, Inc.
Suwanee, GA, US - Received
- August 31, 2012
- Decision date
- December 20, 2012
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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) | Device | Applicant | Decision |
|---|---|---|---|
| K060320 | Femecc Endocervical CurettePCF · Traditional | Femspec LLC | 07/28/2006SE |
| K882606 | Euro-Med Endo-CurettePCF · Traditional | Buckman Co., Inc. | 07/25/1988SE |
| K882404 | Kevor-CurettePCF · Traditional | Euro-Med Intl. | 07/08/1988SE |
| K860796 | Dispo-UrettePCF · Traditional | Roland J. Zwick, Inc. | 04/08/1986SE |
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| K100662 | Femvue Cornual Balloon CatheterLKF · Special | 04/07/2010SE |
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Questions and answers
When was Femcerv Endocervical Sampler Model 3 Sizes: Ref FCV-013, Ref FCV-011, Ref FCV-009 cleared by the FDA?
Femcerv Endocervical Sampler Model 3 Sizes: Ref FCV-013, Ref FCV-011, Ref FCV-009 (K122658) received a 510(k) decision of Substantially Equivalent on December 20, 2012, 111 days after the submission was received.
What is the product code of K122658?
The FDA product code is PCF – Sampler, Endocervical, a Class II (moderate risk) device regulated under 21 CFR 884.1050.