Product code KYZ
- Device name
- Syringe, Irrigating (Non Dental)
- Medical specialty
- General Hospital
- Device class
- 1
- Regulation number
- 880.6960
- Review panel
- HO
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- Y
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K201877 | OtoSet- Ear Cleaning System | Safkan, Inc. | 2020-11-05 |
| K102563 | SINGLE CANNULA EXTENDED APPLICATOR | Micromedics, Inc. | 2011-03-15 |
| K092022 | TISSU TRANS HARVEST TUBING | Shippert Medical Technologies Corp. | 2009-08-17 |
| K050797 | TISSU-TRANS | Shippert Medical Technologies Corp. | 2005-07-13 |
| K991254 | QS DELIVERY SYSTEM | Sub-Q, Inc. | 1999-08-23 |
| K982435 | IRRIGATION SYRINGE KIT | Sub-Q, Inc. | 1998-11-06 |
| K974288 | ZEROWET SPLASHIELD | Zerowet, Inc. | 1998-01-29 |
| K964833 | RMI DUAL FLUID IRRIGATING SYRINGE | Research Medical, Inc. | 1997-02-19 |
| K960725 | MARPP PRESSURE MONITORING SYSTEM | Paradigm Medical, Inc. | 1996-07-15 |
| K960212 | CPR IRRIGATION TRAY | Custom Pack Reliability | 1996-04-01 |
| K952407 | REDI NURSE SYSTEM (RNS) PRE-FILLED 10CC, 30CC, 60CC SYRINGE W/STERILE WATER | Contour Fabricators of Florida, Inc. | 1995-08-07 |
| K952406 | REDI NURSE SYSTEM (RNS) PRE-FILLED 60CC IRRIGATION SYRINGE W/STERILE SODIUM CHLORIDE SOLUTION | Contour Fabricators of Florida, Inc. | 1995-08-07 |
| K933171 | INMAN IRRIGATION TAPERED PROBE | Inman Medical Corp. | 1994-04-29 |
| K940371 | SURGICAL SEALANT APPLICATOR TIP ENDOSCOPIC TIP | Micromedics, Inc. | 1994-04-06 |
| K930610 | TALC DISPENSER SYRINGE | Nusurg, Inc. | 1993-11-04 |
| K924517 | AVITENE DISPENSER SYRINGE | Nusurg, Inc. | 1993-10-27 |
| K931912 | IRRIGATING BLUNT DISSECTOR | Mayaguez Medical Center | 1993-08-10 |
| K931946 | WELCH ALLYN EARCLEANER | Welch Allyn, Inc. | 1993-07-26 |
| K924809 | IRRIGATION TRAY W/ BULB SYRINGE | Customed, Inc. | 1993-06-07 |
| K905173 | SPLASH GUARD | E.M. Adams | 1991-04-25 |
| K905365 | INSTRUMENT MAKAR GRAVITY ASSIST SYSTEM | Instrument Makar, Inc. | 1991-02-06 |
| K903759 | IRRICLEAR EAR IRRIGATION SYRINGE | Nortech Laboratories, Inc. | 1990-10-26 |
| K900208 | ZEROWET SPLASHIELD | Zerowet Splashield | 1990-09-04 |
| K902854 | GRAVITY ASSIST | Instrument Makar, Inc. | 1990-08-29 |
| K896800 | IRRIGATION TRAY | Westmark, Sterile Packing Systems, Inc. (Sps) | 1990-05-24 |
| K894470 | STRYKER TRAUMA TRAY | Stryker Corp. | 1989-08-18 |
| K890728 | STERILE IRRIGATION TRAYS | Cypress Medical Products, Ltd. | 1989-06-16 |
| K884786 | EAR IRRIGATION SET 101 (EARIGATOR) | Physicians Supply Co. | 1989-04-26 |
| K884749 | JOHNSON & JOHNSON STERILE SPRAY TIP SYRINGE | Johnson & Johnson Patient Care, Inc. | 1988-12-15 |
| K883506 | IRRIGATION KIT | L H M Ent., Inc. | 1988-12-13 |
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| 08714729748342 | Rapid Refill | BOSTON SCIENTIFIC CORPORATION | 2016-09-24 |