21 CFR 886.4790 — Sponge, Ophthalmic
Ophthalmic (OP) · Part 886 Subpart E—Surgical Devices · § 886.4790
Identification
An ophthalmic sponge is a device that is an absorbant sponge, pad, or spear made of folded gauze, cotton, cellulose, or other material intended to absorb fluids from the operative field in ophthalmic surgery.
Classification Rationale
Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 886.9.
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| HOZ | Sponge, Ophthalmic | 2 | 47 | |
| OJK | Eye Tray | 2 | 0 |
Special Controls
HOZ — Sponge, Ophthalmic
*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 886.9.
eCFR
OJK — Eye Tray
*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 886.9.
eCFR
