Tray, Surgical, Ent
The ENT Surgical Tray is a pre-assembled set of surgical instruments and supplies organized for use during ear, nose, and throat surgical procedures, providing clinicians with a standardized kit of tools needed for ENT interventions. Classified as a Class 1 device under 21 CFR 874.4420 within the Ear, Nose, and Throat specialty, it is subject to general controls only and is generally exempt from 510(k) premarket notification. It carries no implant or life-sustaining flags.
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Basic Information
- Product Code
- MMO
- Device Class
- FDA class 1
- Regulation Number
- 874.4420
- Medical Specialty
- Ear, Nose, Throat
- Review Panel
- EN
- 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 |
|---|---|---|---|---|
| K771049 | ENDOSCOPIC TRAY | Sep 12, 1977 | Substantially Equivalent | American Hospital Supply Corp. |
FEI Numbers
This FDA classification entry is associated with 52 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 52 registration numbers. Click on an entry to view related FDA registrations.