Product Code: LXZ FDA class 1 21 CFR 878.4800

Guard, Instrument

General, Plastic Surgery

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.

510(k)s
2
FEI Numbers
25
Registration Numbers
25
Unique Applicants
2
Years Active
12

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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

GMP Exempt
Implant
Life Sustain/Support
Third Party
Summary Malfunction Reporting

510(k) Clearance History

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Related 510(k) Clearances

This FDA classification is associated with 2 510(k) clearances via K numbers.

K Number Device Name
K955463 GRIP-A-BOOTS
K834127 INSTRUMENT TIP PROTECTION COVERS

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.