21 CFR 880.6880 — Sterilizer, Steam
General Hospital (HO) · Part 880 Subpart G—General Hospital and Personal Use Miscellaneous Devices · § 880.6880
Identification
A steam sterilizer (autoclave) is a device that is intended for use by a health care provider to sterilize medical products by means of pressurized steam.
Classification Rationale
Class II (performance standards).
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| FLE | Sterilizer, Steam | 2 | 184 | 3rd Party |
| PEC | Sterilizer Automated Loading System | 2 | 1 | 3rd Party |