Drum, Eye Knife Test
The Eye Knife Test Drum is an ophthalmic instrument accessory used to test and assess the sharpness and quality of ophthalmic surgical knives and blades before or during surgical procedures, ensuring that cutting instruments meet functional standards. It is classified as FDA Class 1, the lowest risk category, requiring only general controls without a premarket notification requirement. The product code is HMS, regulated under 21 CFR 886.4230, within the Ophthalmic medical specialty. This device is exempt from Good Manufacturing Practice (GMP) requirements under 21 CFR Part 820.
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Basic Information
- Product Code
- HMS
- Device Class
- FDA class 1
- Regulation Number
- 886.4230
- Medical Specialty
- Ophthalmic
- Review Panel
- OP
- Submission Type
- 4
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 1 510(k) clearance via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K926412 | MICRON-SCOPE II | Jul 19, 1994 | Substantially Equivalent | Chiron Vision Corp. |