21 CFR 886.4360 — Device, Irrigation, Ocular Surgery
Ophthalmic (OP) · Part 886 Subpart E—Surgical Devices · § 886.4360
Identification
An ocular surgery irrigation device is a device intended to be suspended over the ocular area during ophthalmic surgery to deliver continuous, controlled irrigation to the surgical field.
Classification Rationale
Class I (general 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 |
|---|---|---|---|---|
| KYG | Device, Irrigation, Ocular Surgery | 1 | 40 |
