21 CFR § 884.6140 Obstetrical and Gynecological Devices

§ 884.6140 Assisted reproduction micropipette fabrication instruments.

Current through Sep 8, 2026 · Read all of Part 884

(a) Identification. Assisted reproduction micropipette fabrication devices are instruments intended to pull, bevel, or forge a micropipette or needle for intracytoplasmic sperm injection (ICSI), in vitro fertilization (IVF) or other similar assisted reproduction procedures.

(b) Classification. Class II (special controls) (design specifications, labeling requirements, and clinical testing).

← § 884.6130 Assisted reproduction microtools.§ 884.6150 Assisted reproduction micromanipulators and microinjectors. →