---
kind: "section"
citation: "21 C.F.R. § 884.4520"
title: "21"
number: "884.4520"
heading: "Obstetric-gynecologic general manual instrument."
url: "https://uscodex.org/cfr/21/884.4520"
---

# §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](/cfr/21/part807-subpartE.md) of this chapter, subject to the limitations in [§ 884.9](/cfr/21/884.9.md).

## Notes

### Amendments

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

### Authority

Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360 l , 371.

### Source

Source: 45 FR 12684, Feb. 26, 1980, unless otherwise noted.

### Amendments

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