Guard, Instrument
The Instrument Guard (product code LXZ) is a protective accessory used to cover or shield surgical instrument tips and blades during handling, transport, or storage, preventing injury to personnel and damage to instrument edges. Regulated under 21 CFR 878.4800 and classified as a Class 1 device subject only to general controls, it falls under the General and Plastic Surgery specialty. It is not an implant, is not life-sustaining, and is eligible for third-party review.
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Basic Information
- Product Code
- LXZ
- Device Class
- FDA class 1
- Regulation Number
- 878.4800
- Medical Specialty
- General, Plastic Surgery
- Review Panel
- SU
- Submission Type
- 4
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 2 510(k) clearances via K numbers.
FEI Numbers
This FDA classification entry is associated with 25 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 25 registration numbers. Click on an entry to view related FDA registrations.