Pope Oto-Wick, Sterile & Non-Sterile
FDA 510(k) K791059 · Xomed, Inc.
510(k) numberK791059
Submission
- Device name
- Pope Oto-Wick, Sterile & Non-Sterile
- Applicant
- Xomed, Inc.
Arnold, MO, US - Received
- June 8, 1979
- Decision date
- July 17, 1979
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- KCN – Ear Wick
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 874.5220
- Specialty
- Ear, Nose, Throat
Other 510(k)s with product code KCN
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K062540 | Nasopore Ear, Models ND04, ND05KCN · Traditional | Polyganics B.V., | 10/18/2006SE |
| K973578 | Invotec Ear Tampon (Wick) W/StringKCN · Traditional | Invotec International, Inc. | 11/06/1997SE |
| K920357 | Ultracell Ear WickKCN · Traditional | Ultracell Medical Technologies, Inc. | 02/01/1993SE |
More from Ultracell Medical Technologies, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K002395 | Model 30 Classic PneumatonometerHKX · Traditional | 12/11/2000SE |
| K002987 | Redtronic Xomed Monopolar Energized BladeGEI · Traditional | 12/04/2000SE |
| K002828 | XPS Nitro SystemERL · Traditional | 10/17/2000SE |
| K002897 | Titanium Middle Ear ProsthesesETB · Traditional | 10/11/2000SE |
| K993653 | Micro-France Trocars and AccessoriesHET · Traditional | 06/09/2000SE |
| K001148 | Merogel Otologic PackKHJ · Traditional | 06/03/2000SE |
| K994262 | Frontal Sinus Trephination CannulaKAM · Traditional | 02/08/2000SE |
| K992855 | XPS Straightshot or Model 2000 Microdebrider System or XPS PowersculptQPB · Traditional | 01/21/2000SE |
| K993582 | Modification to Laser-Shield IIBTR · Traditional | 01/20/2000SE |
| K993655 | Micro-France Electrosurgical Instruments, VariousGEI · Traditional | 12/21/1999SE |
Questions and answers
When was Pope Oto-Wick, Sterile & Non-Sterile cleared by the FDA?
Pope Oto-Wick, Sterile & Non-Sterile (K791059) received a 510(k) decision of Substantially Equivalent on July 17, 1979, 39 days after the submission was received.
What is the product code of K791059?
The FDA product code is KCN – Ear Wick, a Class I (low risk) device regulated under 21 CFR 874.5220.