Forceps, Ent
ENT forceps are surgical grasping instruments specifically designed for use in ear, nose, and throat procedures, used to hold, manipulate, or remove tissue, foreign bodies, or other materials within anatomical structures of the head and neck. The device is classified as FDA Class 1, the lowest risk tier, and is subject only to general controls without requiring premarket clearance. Product code KAE 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
- KAE
- 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 14 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K853708 | LARYNGASCOPES, FORCEPS, MICRO SUCTION TUBE & REFLE | Feb 14, 1986 | Substantially Equivalent | Downs Surgical , Ltd. |
| K851795 | 41-250 TO 41-282 VARIOUS NASAL CUTTING FORCEPS | Jun 11, 1985 | Substantially Equivalent | Artiberia |
| K851794 | 41-180 TO 41-246 VARIOUS NASAL FORCEPS | Jun 11, 1985 | Substantially Equivalent | Artiberia |
| K851775 | 19-790 TO 19-1042 DRESSING/SPONGE FORCEPS | Jun 11, 1985 | Substantially Equivalent | Artiberia |
| K833608 | GOLD ALLIGATOR FORCEPS | Jan 11, 1984 | Substantially Equivalent | Microtek Medical, Inc. |
| K833607 | MCGEE FORCEPS | Jan 03, 1984 | Substantially Equivalent | Microtek Medical, Inc. |
| K833605 | CUPPED FORCEPS | Jan 03, 1984 | Substantially Equivalent | Microtek Medical, Inc. |
| K822372 | OFFICE ECONO-FORCEPS | Sep 09, 1982 | Substantially Equivalent | Treace Medical, Inc. |
| K822369 | MICRO & MINI-MICRO ALLIGATOR FORCEPS | Sep 09, 1982 | Substantially Equivalent | Treace Medical, Inc. |
| K812895 | YARMO NASAL CARTILAGE SOFTENER | Nov 02, 1981 | Substantially Equivalent | American V. Mueller |
| K772398 | COTTLE LOWER LATERAL FORCEPS | Jan 17, 1978 | Substantially Equivalent | Edward Weck, Inc. |
| K772397 | COTTLE COLUMELLA FORCEP | Jan 17, 1978 | Substantially Equivalent | Edward Weck, Inc. |
| K772396 | ALLIGATOR CUP FORCEPS | Jan 17, 1978 | Substantially Equivalent | Edward Weck, Inc. |
| K772377 | HILDYARD POST NASAL FORCEP | Jan 17, 1978 | Substantially Equivalent | Edward Weck, Inc. |
FEI Numbers
This FDA classification entry is associated with 222 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 222 registration numbers. Click on an entry to view related FDA registrations.