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Packer, Uterine

Page Type
Product Code
Regulation Medical Specialty
Obstetrical and Gynecological
Review Panel
Obstetrical and Gynecological
Submission Type
510(K) Exempt
Device Classification
Class 1
Regulation Number
884.4520
GMP Exempt?
No
Summary Malfunction Reporting
Eligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

CFR § 884.4520 Obstetric-gynecologic general manual instrument

§ 884.4520 Obstetric-gynecologic general manual instrument.

(a) Identification. An obstetric-gynecologic general manual instrument is one of a group of devices used to perform simple obstetric and gynecologic manipulative functions. This generic type of device consists of the following:

(1) An episiotomy scissors is a cutting instrument, with two opposed shearing blades, used for surgical incision of the vulvar orifice for obstetrical purposes.

(2) A fiberoptic metal vaginal speculum is a metal instrument, with fiberoptic light, used to expose and illuminate the interior of the vagina.

(3) A metal vaginal speculum is a metal instrument used to expose the interior of the vagina.

(4) An umbilical scissors is a cutting instrument, with two opposed shearing blades, used to cut the umbilical cord.

(5) A uterine clamp is an instrument used to hold the uterus by compression.

(6) A uterine packer is an instrument used to introduce dressing into the uterus or vagina.

(7) A vaginal applicator is an instrument used to insert medication into the vagina.

(8) A vaginal retractor is an instrument used to maintain vaginal exposure by separating the edges of the vagina and holding back the tissue.

(9) A gynecological fibroid hook is an instrument used to exert traction upon a fibroid.

(10) A pelvimeter (external) is an instrument used to measure the external diameters of the pelvis.

(b) Classification. Class I (general controls). The devices are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 884.9.

[45 FR 12684, Feb. 26, 1980, as amended at 54 FR 25052, June 12, 1989; 66 FR 38809, July 25, 2001]

Packer, Uterine

Page Type
Product Code
Regulation Medical Specialty
Obstetrical and Gynecological
Review Panel
Obstetrical and Gynecological
Submission Type
510(K) Exempt
Device Classification
Class 1
Regulation Number
884.4520
GMP Exempt?
No
Summary Malfunction Reporting
Eligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

CFR § 884.4520 Obstetric-gynecologic general manual instrument

§ 884.4520 Obstetric-gynecologic general manual instrument.

(a) Identification. An obstetric-gynecologic general manual instrument is one of a group of devices used to perform simple obstetric and gynecologic manipulative functions. This generic type of device consists of the following:

(1) An episiotomy scissors is a cutting instrument, with two opposed shearing blades, used for surgical incision of the vulvar orifice for obstetrical purposes.

(2) A fiberoptic metal vaginal speculum is a metal instrument, with fiberoptic light, used to expose and illuminate the interior of the vagina.

(3) A metal vaginal speculum is a metal instrument used to expose the interior of the vagina.

(4) An umbilical scissors is a cutting instrument, with two opposed shearing blades, used to cut the umbilical cord.

(5) A uterine clamp is an instrument used to hold the uterus by compression.

(6) A uterine packer is an instrument used to introduce dressing into the uterus or vagina.

(7) A vaginal applicator is an instrument used to insert medication into the vagina.

(8) A vaginal retractor is an instrument used to maintain vaginal exposure by separating the edges of the vagina and holding back the tissue.

(9) A gynecological fibroid hook is an instrument used to exert traction upon a fibroid.

(10) A pelvimeter (external) is an instrument used to measure the external diameters of the pelvis.

(b) Classification. Class I (general controls). The devices are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 884.9.

[45 FR 12684, Feb. 26, 1980, as amended at 54 FR 25052, June 12, 1989; 66 FR 38809, July 25, 2001]