Sampler, Endocervical
The Endocervical Sampler is a gynecological device used to obtain tissue samples from the endocervical canal for histological analysis, typically as part of cervical cancer screening or evaluation of abnormal Pap smear results. It falls under the Obstetrics/Gynecology medical specialty and is classified as a Class 2 device under regulation 884.1050, requiring 510(k) premarket notification. The device is eligible for third-party review and is subject to general controls and special controls. It is not an implant and is not life-sustaining.
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Basic Information
- Product Code
- PCF
- Device Class
- FDA class 2
- Regulation Number
- 884.1050
- Medical Specialty
- Obstetrics/Gynecology
- Review Panel
- OB
- Submission Type
- 1
Device Characteristics
Definition
Obtains tissue samples from the endocervical canal for histological analysis.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 5 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K122658 | FEMCERV ENDOCERVICAL SAMPLER MODEL 3 SIZES: REF FCV-013, REF FCV-011, REF FCV-009 | Dec 20, 2012 | Substantially Equivalent | Femasys, Inc. |
| K060320 | FEMECC ENDOCERVICAL CURETTE | Jul 28, 2006 | Substantially Equivalent | Femspec LLC |
| K882606 | EURO-MED ENDO-CURETTE | Jul 25, 1988 | Substantially Equivalent | Buckman Co., Inc. |
| K882404 | KEVOR-CURETTE | Jul 08, 1988 | Substantially Equivalent | Euro-Med Intl. |
| K860796 | DISPO-URETTE | Apr 08, 1986 | Substantially Equivalent | Roland J. Zwick, Inc. |
FEI Numbers
This FDA classification entry is associated with 6 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 6 registration numbers. Click on an entry to view related FDA registrations.