IRRIGATION TRAY W/ BULB SYRINGE
FDA 510(k) clearance K924809 · decided 1993-06-07
Clearance details
- K-number
- K924809
- Device name
- IRRIGATION TRAY W/ BULB SYRINGE
- Applicant
- Customed, Inc.
- Decision
- Unknown
- Date received
- 1992-09-24
- Decision date
- 1993-06-07
- Days to decision
- 256 days
- Clearance type
- Traditional
- Product code
- KYZ
- Device class
- 1
- Regulation number
- 880.6960
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Fajardo, PR, US
- Third-party review
- No
- Expedited review
- No
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| ZEROWET SPLASHIELD (K974288) | Zerowet, Inc. | 1998-01-29 |
| RMI DUAL FLUID IRRIGATING SYRINGE (K964833) | Research Medical, Inc. | 1997-02-19 |
| MARPP PRESSURE MONITORING SYSTEM (K960725) | Paradigm Medical, Inc. | 1996-07-15 |
| CPR IRRIGATION TRAY (K960212) | Custom Pack Reliability | 1996-04-01 |
| REDI NURSE SYSTEM (RNS) PRE-FILLED 60CC IRRIGATION SYRINGE W/STERILE SODIUM CHLORIDE SOLUTION (K952406) | Contour Fabricators of Florida, Inc. | 1995-08-07 |
| REDI NURSE SYSTEM (RNS) PRE-FILLED 10CC, 30CC, 60CC SYRINGE W/STERILE WATER (K952407) | Contour Fabricators of Florida, Inc. | 1995-08-07 |
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Catalog Number: 900020 IRRIGATION TRAY WITH IRRIGATION BULB SYRINGE Used by medical staff recall (Z-1400-2016) | Customed, Inc | 2016-04-14 |
| IRRIGATION TRAY W/BULB SYRINGE CUSTOMED 50/CS Used by medical staff to perform patient car recall (Z-2551-2015) | Customed, Inc | 2015-09-03 |
| Irrigation Tray w/Bulb syringe, catalog# 900-020 recall (Z-1252-2012) | Customed, Inc | 2012-03-21 |