Knife, Intraocular Pressure Lowering
The Intraocular Pressure Lowering Knife is a surgical instrument used to cut the trabecular meshwork of the eye in order to reduce intraocular pressure in patients with glaucoma, a procedure that improves aqueous humor outflow from the anterior chamber. It is used in minimally invasive glaucoma surgical techniques. Classified as FDA Class 2 under regulation 878.4400, it requires 510(k) clearance, reviewed under the Ophthalmic panel with a General and Plastic Surgery specialty designation. The device is not an implant and not life-sustaining.
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Basic Information
- Product Code
- QUQ
- Device Class
- FDA class 2
- Regulation Number
- 878.4400
- Medical Specialty
- General, Plastic Surgery
- Review Panel
- OP
- Submission Type
- 1
Device Characteristics
Definition
A knife intended for cutting of trabecular meshwork to reduce intraocular pressure in glaucoma
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 |
|---|---|---|---|---|
| K220891 | Kahook Dual Blade Glide (KDB Glide) | May 17, 2024 | Substantially Equivalent | New World Medical, Inc. |
FEI Numbers
This FDA classification entry is associated with 3 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 3 registration numbers. Click on an entry to view related FDA registrations.