GroundRules
21 CFR 886.3920: Aqueous shunt.
Where this section sits in the code
- Title 21—Food and Drugs
- CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES
- SUBCHAPTER H—MEDICAL DEVICES
- PART 886—OPHTHALMIC DEVICES
- Subpart D—Prosthetic Devices
(a) Identification. An aqueous shunt is an implantable device intended to reduce intraocular pressure in the anterior chamber of the eye in patients with neovascular glaucoma or with glaucoma when medical and conventional surgical treatments have failed.
(b) Classification. Class II. The special controls for this device are FDA's:
(1) “Use of International Standard ISO 10993 ‘Biological Evaluation of Medical Devices—Part I: Evaluation and Testing,’ ”
(2) “510(k) Sterility Review Guidance of 2/12/90 (K90-1),” and
(3) “Aqueous Shunts—510(k) Submissions.”
Collected 2026-08-27T02:24:47Z. Source file · JSON