Retractor, Ent
An ENT retractor is a surgical instrument used to hold back tissue and maintain exposure during ear, nose, and throat surgical procedures, allowing the surgeon access to the operative field. The device is classified as FDA Class 1, indicating low risk, and is subject only to general controls including labeling and manufacturing requirements. Product code KAL is regulated under 21 CFR 874.4420 in the Ear, Nose, Throat medical specialty. No special flags apply to this device.
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Basic Information
- Product Code
- KAL
- 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 5 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K870758 | SMALL MASTOID RETRACTOR | Mar 04, 1987 | Substantially Equivalent | Treace Medical, Inc. |
| K833604 | ADJUSTABLE FORK RETRACTOR | Jan 03, 1984 | Substantially Equivalent | Microtek Medical, Inc. |
| K772392 | ALLPORT MASTOID RETRACTORS | Jan 17, 1978 | Substantially Equivalent | Edward Weck, Inc. |
| K772381 | RING HANDLE & RETRACTORS | Jan 17, 1978 | Substantially Equivalent | Edward Weck, Inc. |
| K760851 | CONVERSE ALTAR RETRACTOR | Mar 10, 1977 | Substantially Equivalent | V. Mueller O.V. Baxter Healthcare Corp. |
FEI Numbers
This FDA classification entry is associated with 120 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 120 registration numbers. Click on an entry to view related FDA registrations.