Last synced on 27 January 2023 at 11:04 pm

Sampler, Endocervical

Page Type
Product Code
Definition
Obtains tissue samples from the endocervical canal for histological analysis.
Physical State
handle and sheath with collection tip; collection tip is designed to scrape endocervical canal and collect an endocervical tissue sample
Technical Method
inserted manually through the vaginal and into the endocervix; collection tip scrapes the endocervical canal and collects endocervical tissue sample
Target Area
cervix
Regulation Medical Specialty
Obstetrical and Gynecological
Review Panel
Obstetrical and Gynecological
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
884.1050
GMP Exempt?
No
Summary Malfunction Reporting
Eligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Third Party Eligible

CFR § 884.1050 Endocervical aspirator

§ 884.1050 Endocervical aspirator.

(a) Identification. An endocervical aspirator is a device designed to remove tissue from the endocervix (mucous membrane lining the canal of the cervix of the uterus) by suction with a syringe, bulb and pipette, or catheter. This device is used to evaluate endocervical tissue to detect malignant and premalignant lesions.

(b) Classification. Class II (performance standards).

Sampler, Endocervical

Page Type
Product Code
Definition
Obtains tissue samples from the endocervical canal for histological analysis.
Physical State
handle and sheath with collection tip; collection tip is designed to scrape endocervical canal and collect an endocervical tissue sample
Technical Method
inserted manually through the vaginal and into the endocervix; collection tip scrapes the endocervical canal and collects endocervical tissue sample
Target Area
cervix
Regulation Medical Specialty
Obstetrical and Gynecological
Review Panel
Obstetrical and Gynecological
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
884.1050
GMP Exempt?
No
Summary Malfunction Reporting
Eligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Third Party Eligible

CFR § 884.1050 Endocervical aspirator

§ 884.1050 Endocervical aspirator.

(a) Identification. An endocervical aspirator is a device designed to remove tissue from the endocervix (mucous membrane lining the canal of the cervix of the uterus) by suction with a syringe, bulb and pipette, or catheter. This device is used to evaluate endocervical tissue to detect malignant and premalignant lesions.

(b) Classification. Class II (performance standards).