FDA Product Code
FDA Product Code KYZ — Clearance Directory
- Device Class
- Class I
- Assigned Panel
- General Hospital
- 21 CFR Citation
- 880.6960
510(k) Clearances — 41 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K201877 | OtoSet- Ear Cleaning System | Safkan, Inc. | 2020-11-05 | Traditional | PDF ↗ |
| K102563 | SINGLE CANNULA EXTENDED APPLICATOR | Micromedics, Inc. | 2011-03-15 | Traditional | PDF ↗ |
| K092022 | TISSU TRANS HARVEST TUBING | Shippert Medical Technologies Corp. | 2009-08-17 | Special | PDF ↗ |
| K050797 | TISSU-TRANS | Shippert Medical Technologies Corp. | 2005-07-13 | Traditional | PDF ↗ |
| K991254 | QS DELIVERY SYSTEM | Sub-Q, Inc. | 1999-08-23 | Traditional | PDF ↗ |
| K982435 | IRRIGATION SYRINGE KIT | Sub-Q, Inc. | 1998-11-06 | Traditional | PDF ↗ |
| K974288 | ZEROWET SPLASHIELD | Zerowet, Inc. | 1998-01-29 | Traditional | PDF ↗ |
| K964833 | RMI DUAL FLUID IRRIGATING SYRINGE | Research Medical, Inc. | 1997-02-19 | Traditional | PDF ↗ |
| K960725 | MARPP PRESSURE MONITORING SYSTEM | Paradigm Medical, Inc. | 1996-07-15 | Traditional | PDF ↗ |
| K960212 | CPR IRRIGATION TRAY | Custom Pack Reliability | 1996-04-01 | Traditional | PDF ↗ |
| K952406 | REDI NURSE SYSTEM (RNS) PRE-FILLED 60CC IRRIGATION SYRINGE W/STERILE SODIUM CHLORIDE SOLUTION | Contour Fabricators of Florida, Inc. | 1995-08-07 | Traditional | PDF ↗ |
| K952407 | REDI NURSE SYSTEM (RNS) PRE-FILLED 10CC, 30CC, 60CC SYRINGE W/STERILE WATER | Contour Fabricators of Florida, Inc. | 1995-08-07 | Traditional | PDF ↗ |
| K933171 | INMAN IRRIGATION TAPERED PROBE | Inman Medical Corp. | 1994-04-29 | Traditional | PDF ↗ |
| K940371 | SURGICAL SEALANT APPLICATOR TIP ENDOSCOPIC TIP | Micromedics, Inc. | 1994-04-06 | Traditional | PDF ↗ |
| K930610 | TALC DISPENSER SYRINGE | Nusurg, Inc. | 1993-11-04 | Traditional | PDF ↗ |
| K924517 | AVITENE DISPENSER SYRINGE | Nusurg, Inc. | 1993-10-27 | Traditional | PDF ↗ |
| K931912 | IRRIGATING BLUNT DISSECTOR | Mayaguez Medical Center | 1993-08-10 | Traditional | PDF ↗ |
| K931946 | WELCH ALLYN EARCLEANER | Welch Allyn, Inc. | 1993-07-26 | Traditional | PDF ↗ |
| K924809 | IRRIGATION TRAY W/ BULB SYRINGE | Customed, Inc. | 1993-06-07 | Traditional | PDF ↗ |
| K905173 | SPLASH GUARD | E.M. Adams | 1991-04-25 | Traditional | PDF ↗ |
| K905365 | INSTRUMENT MAKAR GRAVITY ASSIST SYSTEM | Instrument Makar, Inc. | 1991-02-06 | Traditional | PDF ↗ |
| K903759 | IRRICLEAR EAR IRRIGATION SYRINGE | Nortech Laboratories, Inc. | 1990-10-26 | Traditional | PDF ↗ |
| K900208 | ZEROWET SPLASHIELD | Zerowet Splashield | 1990-09-04 | Traditional | PDF ↗ |
| K902854 | GRAVITY ASSIST | Instrument Makar, Inc. | 1990-08-29 | Traditional | PDF ↗ |
| K896800 | IRRIGATION TRAY | Westmark, Sterile Packing Systems, Inc. (Sps) | 1990-05-24 | Traditional | PDF ↗ |
| K894470 | STRYKER TRAUMA TRAY | Stryker Corp. | 1989-08-18 | Traditional | PDF ↗ |
| K890728 | STERILE IRRIGATION TRAYS | Cypress Medical Products, Ltd. | 1989-06-16 | Traditional | PDF ↗ |
| K884786 | EAR IRRIGATION SET 101 (EARIGATOR) | Physicians Supply Co. | 1989-04-26 | Traditional | PDF ↗ |
| K884749 | JOHNSON & JOHNSON STERILE SPRAY TIP SYRINGE | Johnson & Johnson Patient Care, Inc. | 1988-12-15 | Traditional | PDF ↗ |
| K883506 | IRRIGATION KIT | L H M Ent., Inc. | 1988-12-13 | Traditional | PDF ↗ |
| K883338 | SURGICAL SEALANT APPLICATOR | Micromedics, Inc. | 1988-08-23 | Traditional | PDF ↗ |
| K881020 | SURGICAL SEALANT DISPENSER (SSD) | Micromedics, Inc. | 1988-03-25 | Traditional | PDF ↗ |
| K830572 | CLEAN-FLUSH | Burron Medical Products, Inc. | 1983-03-17 | Traditional | PDF ↗ |
| K821530 | SYRINGE IRRIGATING | Medcare Disp Products, Inc. | 1982-05-28 | Traditional | PDF ↗ |
| K813027 | STERILE IRRIGATING SYRINGES, KITS,TRAY | Welcon, Inc. | 1981-11-20 | Traditional | PDF ↗ |
| K810251 | SYRINGE, ENT | Megaplast, Inc. | 1981-03-11 | Traditional | PDF ↗ |
| K810209 | IRRIJET | Ackrad Laboratories | 1981-02-17 | Traditional | PDF ↗ |
| K803200 | IRRIGATION SET W/BULB SYRINGE | Walpak Co. | 1981-01-21 | Traditional | PDF ↗ |
| K801573 | SAPCRILL THERMODETECT BREAST SCANNER DEV | California Cardiac Systems, Inc. | 1980-09-09 | Traditional | PDF ↗ |
| K791998 | 60CC IRRIGATING SYRINGE, PISTON TYPE, | Waz Industries, Inc. | 1979-10-26 | Traditional | PDF ↗ |
| K780794 | IRRIGATION CAP | Travenol Laboratories, S.A. | 1978-07-27 | Traditional | PDF ↗ |
Product code KYZ · Class I · General Hospital. Data: openFDA.