{"data":{"id":"us/21-cfr-884.4520","jurisdiction":"us","citation":"21 CFR 884.4520","heading":"Obstetric-gynecologic general manual instrument.","body":"(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:\n(1) An episiotomy scissors is a cutting instrument, with two opposed shearing blades, used for surgical incision of the vulvar orifice for obstetrical purposes.\n(2) A fiberoptic metal vaginal speculum is a metal instrument, with fiberoptic light, used to expose and illuminate the interior of the vagina.\n(3) A metal vaginal speculum is a metal instrument used to expose the interior of the vagina.\n(4) An umbilical scissors is a cutting instrument, with two opposed shearing blades, used to cut the umbilical cord.\n(5) A uterine clamp is an instrument used to hold the uterus by compression.\n(6) A uterine packer is an instrument used to introduce dressing into the uterus or vagina.\n(7) A vaginal applicator is an instrument used to insert medication into the vagina.\n(8) A vaginal retractor is an instrument used to maintain vaginal exposure by separating the edges of the vagina and holding back the tissue.\n(9) A gynecological fibroid hook is an instrument used to exert traction upon a fibroid.\n(10) A pelvimeter (external) is an instrument used to measure the external diameters of the pelvis.\n(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.","path":["Title 21—Food and Drugs","CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES","SUBCHAPTER H—MEDICAL DEVICES","PART 884—OBSTETRICAL AND GYNECOLOGICAL DEVICES","Subpart E—Obstetrical and Gynecological Surgical Devices"],"source_url":"https://www.ecfr.gov/api/versioner/v1/full/2026-08-25/title-21.xml","current_through":"2026-08-25","vintage":"","retrieved_at":"2026-08-27T02:24:47Z","sha256":"9f0c9747be6fa6f2769b676ff13b8a9f41f13605ee7b82dc1930871fb0198090","source_id":"us-cfr","stale":true,"prev":"us/21-cfr-884.4500","next":"us/21-cfr-884.4530"},"notice":"GroundRules: Original legal text. Not legal advice."}