Irriclear Ear Irrigation Syringe
FDA 510(k) K903759 · Nortech Laboratories, Inc.
510(k) numberK903759
Submission
- Device name
- Irriclear Ear Irrigation Syringe
- Applicant
- Nortech Laboratories, Inc.
Dubuque, IA, US - Received
- August 20, 1990
- Decision date
- October 26, 1990
- Decision
- Unknown (SESK)
- Type
- Traditional 510(k)
Device classification
- Product code
- KYZ – Syringe, Irrigating (Non Dental)
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 880.6960
- Specialty
- General Hospital
Other 510(k)s with product code KYZ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K201877 | OtoSet- Ear Cleaning SystemKYZ · Traditional | Safkan, Inc. | 11/05/2020SE |
| K102563 | Single Cannula Extended ApplicatorKYZ · Traditional | Micromedics, Inc. | 03/15/2011SE |
| K092022 | Tissu Trans Harvest TubingKYZ · Special | Shippert Medical Technologies Corp. | 08/17/2009SE |
| K050797 | Tissu-TransKYZ · Traditional | Shippert Medical Technologies Corp. | 07/13/2005SE |
| K991254 | QS Delivery SystemKYZ · Traditional | Sub-Q, Inc. | 08/23/1999SE |
| K982435 | Irrigation Syringe KitKYZ · Traditional | Sub-Q, Inc. | 11/06/1998SE |
| K974288 | Zerowet SplashieldKYZ · Traditional | Zerowet, Inc. | 01/29/1998SE |
| K964833 | Rmi Dual Fluid Irrigating SyringeKYZ · Traditional | Research Medical, Inc. | 02/19/1997SE |
| K960725 | Marpp Pressure Monitoring SystemKYZ · Traditional | Paradigm Medical, Inc. | 07/15/1996SE |
| K960212 | CPR Irrigation TrayKYZ · Traditional | Custom Pack Reliability | 04/01/1996SE |
Questions and answers
When was Irriclear Ear Irrigation Syringe cleared by the FDA?
Irriclear Ear Irrigation Syringe (K903759) received a 510(k) decision of Unknown on October 26, 1990, 67 days after the submission was received.
What is the product code of K903759?
The FDA product code is KYZ – Syringe, Irrigating (Non Dental), a Class I (low risk) device regulated under 21 CFR 880.6960.