Cupped Forceps
FDA 510(k) K833605 · Microtek Medical, Inc.
510(k) numberK833605
Submission
- Device name
- Cupped Forceps
- Applicant
- Microtek Medical, Inc.
Mchenry, IL, US - Received
- October 12, 1983
- Decision date
- January 3, 1984
- 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 |
|---|---|---|---|
| K853708 | Laryngascopes, Forceps, Micro Suction Tube & RefleKAE · Traditional | Downs Surgical , Ltd. | 02/14/1986SE |
| 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 |
| 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 |
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| K110358 | Venodyne V810JOW · Traditional | 05/05/2011SE |
| K102971 | Freedomaire III Surgical Helmet System Model 10322STKFYA · Traditional | 02/23/2011SE |
| K062899 | Microtek Medical Surgical Gown/TogaFYA · Traditional | 01/25/2007SE |
| K060200 | Microtek Medical Warming DrapeKKX · Traditional | 05/31/2006SE |
| K050322 | Microtek Equipment DrapesKKX · Traditional | 05/17/2005SE |
| K022903 | ChillbusterDWJ · Traditional | 11/27/2002SE |
| K020956 | Vivosonic Dianostic Ultrasound Imaging Coupling MediaMUI · Traditional | 05/16/2002SE |
| K011318 | Venodyne DVT Advantage PlusJOW · Traditional | 10/25/2001SE |
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Questions and answers
When was Cupped Forceps cleared by the FDA?
Cupped Forceps (K833605) received a 510(k) decision of Substantially Equivalent on January 3, 1984, 83 days after the submission was received.
What is the product code of K833605?
The FDA product code is KAE – Forceps, Ent, a Class I (low risk) device regulated under 21 CFR 874.4420.