Laryngascopes, Forceps, Micro Suction Tube & Refle
FDA 510(k) K853708 · Downs Surgical , Ltd.
510(k) numberK853708
Submission
- Device name
- Laryngascopes, Forceps, Micro Suction Tube & Refle
- Applicant
- Downs Surgical , Ltd.
Wilmington, MA, US - Received
- September 4, 1985
- Decision date
- February 14, 1986
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- KAE – Forceps, Ent
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 874.4420
- Specialty
- Ear, Nose, Throat
Other 510(k)s with product code KAE
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K851795 | 41-250 to 41-282 Various Nasal Cutting ForcepsKAE · Traditional | Artiberia | 06/11/1985SE |
| K851794 | 41-180 to 41-246 Various Nasal ForcepsKAE · Traditional | Artiberia | 06/11/1985SE |
| K851775 | 19-790 to 19-1042 Dressing/Sponge ForcepsKAE · Traditional | Artiberia | 06/11/1985SE |
| K833608 | Gold Alligator ForcepsKAE · Traditional | Microtek Medical, Inc. | 01/11/1984SE |
| K833607 | Mcgee ForcepsKAE · Traditional | Microtek Medical, Inc. | 01/03/1984SE |
| K833605 | Cupped ForcepsKAE · Traditional | Microtek Medical, Inc. | 01/03/1984SE |
| K822372 | Office Econo-ForcepsKAE · Traditional | Treace Medical, Inc. | 09/09/1982SE |
| K822369 | Micro & Mini-Micro Alligator ForcepsKAE · Traditional | Treace Medical, Inc. | 09/09/1982SE |
| K812895 | Yarmo Nasal Cartilage SoftenerKAE · Traditional | American V. Mueller | 11/02/1981SE |
| K772398 | Cottle Lower Lateral ForcepsKAE · Traditional | Edward Weck, Inc. | 01/17/1978SE |
More from Edward Weck, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K903750 | Islam Sternal Puncture Needle, Cat #AG-598-OO-EGDM · Traditional | 10/31/1990SE |
| K903749 | Islam Sternal Puncture Needle, Cat #AG-596-00-UGDM · Traditional | 10/31/1990SE |
| K903748 | Islam Sternal Puncture Needle, Cat # AF-594-00-VGDM · Traditional | 10/31/1990SE |
| K903747 | Islam Sternal Puncture Needle, Cat # AG-592-00-UGDM · Traditional | 10/31/1990SE |
| K900616 | Shepperd Cutting ForcepsHRX · Traditional | 10/22/1990SE |
| K900615 | Shepperd Nerve Root Retractor W/Suction & FibreHRX · Traditional | 10/22/1990SE |
| K900614 | Shepperd Short Muscle Retractor (GS-501-45-V)HRX · Traditional | 10/22/1990SE |
| K900613 | Shepperd Shelter Tube Complete & DrillHRX · Traditional | 10/22/1990SE |
| K900612 | Shepperd Trephine Set (GS-501-30-V)HRX · Traditional | 10/22/1990SE |
| K900611 | Shepperd Dilatation Tube Set (GS-501-20-H)HRX · Traditional | 10/22/1990SE |
Questions and answers
When was Laryngascopes, Forceps, Micro Suction Tube & Refle cleared by the FDA?
Laryngascopes, Forceps, Micro Suction Tube & Refle (K853708) received a 510(k) decision of Substantially Equivalent on February 14, 1986, 163 days after the submission was received.
What is the product code of K853708?
The FDA product code is KAE – Forceps, Ent, a Class I (low risk) device regulated under 21 CFR 874.4420.