21 CFR § 886.3920 - Aqueous shunt.

---
identifier: "/us/cfr/t21/s886.3920"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 886.3920 - Aqueous shunt."
title_number: 21
title_name: "Food and Drugs"
section_number: "886.3920"
section_name: "Aqueous shunt."
chapter_name: "FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES"
subchapter_number: "H"
subchapter_name: "MEDICAL DEVICES"
part_number: "886"
part_name: "OPHTHALMIC DEVICES"
positive_law: false
currency: "2026-04-05"
last_updated: "2026-04-05"
format_version: "1.1.0"
generator: "[email protected]"
authority: "21 U.S.C. 351, 360, 360c, 360e, 360j, 360 371."
regulatory_source: "52 FR 33355, Sept. 2, 1987, unless otherwise noted."
cfr_part: "886"
---


# 886.3920 Aqueous shunt.

(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.”

[65 FR 17147, Mar. 31, 2000, as amended at 66 FR 18542, Apr. 10, 2001]