Irrigating Blunt Dissector
FDA 510(k) K931912 · Mayaguez Medical Center
510(k) numberK931912
Submission
- Device name
- Irrigating Blunt Dissector
- Applicant
- Mayaguez Medical Center
Trophy Club, TX, US - Received
- April 16, 1993
- Decision date
- August 10, 1993
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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
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| 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 |
More from Custom Pack Reliability
| 510(k) | Device | Decision |
|---|---|---|
| K932805 | 10.0MM Suction/Irrigation Probe & Tubing KitGCJ · Traditional | 08/16/1993SE |
| K932804 | Irrigating Tapered ProbeGCJ · Traditional | 08/16/1993SE |
| K932806 | Poole Tip Suction Probe & Tubing KitGCJ · Traditional | 08/11/1993SE |
| K931950 | Poole Tip Suction ProbeGCY · Traditional | 08/11/1993SE |
| K931856 | 5.0 MM Irrigation/Aspiration ProbeGCY · Traditional | 08/10/1993SE |
| K931854 | Endoscopic Blunt Dissecting InstrumentFGS · Traditional | 08/10/1993SE |
| K931707 | Endoscopic Cable/Wire CoverGCJ · Traditional | 08/06/1993SE |
| K931706 | Endoscopic Cable DrapeGCJ · Traditional | 08/06/1993SE |
| K931705 | Endoscopic Instrument HolderGCJ · Traditional | 07/22/1993SE |
Questions and answers
When was Irrigating Blunt Dissector cleared by the FDA?
Irrigating Blunt Dissector (K931912) received a 510(k) decision of Substantially Equivalent on August 10, 1993, 116 days after the submission was received.
What is the product code of K931912?
The FDA product code is KYZ – Syringe, Irrigating (Non Dental), a Class I (low risk) device regulated under 21 CFR 880.6960.