Last synced on 23 September 2022 at 11:05 pm

Needle, Assisted Reproduction

Page Type
Product Code
Regulation Medical Specialty
Obstetrical and Gynecological
Review Panel
Obstetrical and Gynecological
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
884.6100
GMP Exempt?
No
Summary Malfunction Reporting
Eligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Third Party Eligible

CFR § 884.6100 Assisted reproduction needles

§ 884.6100 Assisted reproduction needles.

(a) Identification. Assisted reproduction needles are devices used in in vitro fertilization (IVF), gamete intrafallopian transfer (GIFT), or other assisted reproduction procedures to obtain gametes from the body or introduce gametes, zygote(s), preembryo(s) and/or embryo(s) into the body. This generic type of device may include a single or double lumen needle and component parts, including needle guides, such as those used with ultrasound.

(b) Classification. Class II (special controls) (mouse embryo assay information, endotoxin testing, sterilization validation, design specifications, labeling requirements, biocompatibility testing, and clinical testing).

Needle, Assisted Reproduction

Page Type
Product Code
Regulation Medical Specialty
Obstetrical and Gynecological
Review Panel
Obstetrical and Gynecological
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
884.6100
GMP Exempt?
No
Summary Malfunction Reporting
Eligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Third Party Eligible

CFR § 884.6100 Assisted reproduction needles

§ 884.6100 Assisted reproduction needles.

(a) Identification. Assisted reproduction needles are devices used in in vitro fertilization (IVF), gamete intrafallopian transfer (GIFT), or other assisted reproduction procedures to obtain gametes from the body or introduce gametes, zygote(s), preembryo(s) and/or embryo(s) into the body. This generic type of device may include a single or double lumen needle and component parts, including needle guides, such as those used with ultrasound.

(b) Classification. Class II (special controls) (mouse embryo assay information, endotoxin testing, sterilization validation, design specifications, labeling requirements, biocompatibility testing, and clinical testing).