Product Code: KYZ
FDA class 1
21 CFR 880.6960
Syringe, Irrigating (Non Dental)
General Hospital
The Non-Dental Irrigating Syringe is a general-purpose medical syringe used to flush or irrigate wounds, body cavities, or tissue sites with fluid during clinical procedures, distinct from syringes intended for dental use. It is classified as FDA Class 1, the lowest risk category, subject to general controls only, and is exempt from Good Manufacturing Practice (GMP) requirements. The product code is KYZ, regulated under 21 CFR 880.6960, in the General Hospital medical specialty. This device is GMP exempt.
510(k)s
41
FEI Numbers
378
Registration Numbers
378
Unique Applicants
33
Years Active
42
Basic Information
- Product Code
- KYZ
- Device Class
- FDA class 1
- Regulation Number
- 880.6960
- Medical Specialty
- General Hospital
- Review Panel
- HO
- Submission Type
- 4
Device Characteristics
✓
GMP Exempt
✗
Implant
✗
Life Sustain/Support
✗
Third Party
—
Summary Malfunction Reporting
510(k) Clearance History
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Related 510(k) Clearances
This FDA classification is associated with 41 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K201877 | OtoSet- Ear Cleaning System | Nov 05, 2020 | Substantially Equivalent | SafKan, Inc. |
| K102563 | SINGLE CANNULA EXTENDED APPLICATOR | Mar 15, 2011 | Substantially Equivalent | MICROMEDICS, INC. |
| K092022 | TISSU TRANS HARVEST TUBING | Aug 17, 2009 | Substantially Equivalent | SHIPPERT MEDICAL TECHNOLOGIES CORP. |
| K050797 | TISSU-TRANS | Jul 13, 2005 | Substantially Equivalent | SHIPPERT MEDICAL TECHNOLOGIES CORP. |
| K991254 | QS DELIVERY SYSTEM | Aug 23, 1999 | Substantially Equivalent | SUB-Q, INC. |
| K982435 | IRRIGATION SYRINGE KIT | Nov 06, 1998 | Substantially Equivalent | SUB-Q, INC. |
| K974288 | ZEROWET SPLASHIELD | Jan 29, 1998 | Substantially Equivalent | ZEROWET, INC. |
| K964833 | RMI DUAL FLUID IRRIGATING SYRINGE | Feb 19, 1997 | Substantially Equivalent | RESEARCH MEDICAL, INC. |
| K960725 | MARPP PRESSURE MONITORING SYSTEM | Jul 15, 1996 | Substantially Equivalent | PARADIGM MEDICAL, INC. |
| K960212 | CPR IRRIGATION TRAY | Apr 01, 1996 | Substantially Equivalent | CUSTOM PACK RELIABILITY |
| K952407 | REDI NURSE SYSTEM (RNS) PRE-FILLED 10CC, 30CC, 60CC SYRINGE W/STERILE WATER | Aug 07, 1995 | Substantially Equivalent | CONTOUR FABRICATORS OF FLORIDA, INC. |
| K952406 | REDI NURSE SYSTEM (RNS) PRE-FILLED 60CC IRRIGATION SYRINGE W/STERILE SODIUM CHLORIDE SOLUTION | Aug 07, 1995 | Substantially Equivalent | CONTOUR FABRICATORS OF FLORIDA, INC. |
| K933171 | INMAN IRRIGATION TAPERED PROBE | Apr 29, 1994 | Substantially Equivalent | INMAN MEDICAL CORP. |
| K940371 | SURGICAL SEALANT APPLICATOR TIP ENDOSCOPIC TIP | Apr 06, 1994 | Substantially Equivalent | MICROMEDICS, INC. |
| K930610 | TALC DISPENSER SYRINGE | Nov 04, 1993 | Substantially Equivalent | NUSURG, INC. |
| K924517 | AVITENE DISPENSER SYRINGE | Oct 27, 1993 | Substantially Equivalent | NUSURG, INC. |
| K931912 | IRRIGATING BLUNT DISSECTOR | Aug 10, 1993 | Substantially Equivalent | MAYAGUEZ MEDICAL CENTER |
| K931946 | WELCH ALLYN EARCLEANER | Jul 26, 1993 | Substantially Equivalent | WELCH ALLYN, INC. |
| K924809 | IRRIGATION TRAY W/ BULB SYRINGE | Jun 07, 1993 | Unknown | CUSTOMED, INC. |
| K905173 | SPLASH GUARD | Apr 25, 1991 | Substantially Equivalent | E.M. ADAMS |
| K905365 | INSTRUMENT MAKAR GRAVITY ASSIST SYSTEM | Feb 06, 1991 | Substantially Equivalent | INSTRUMENT MAKAR, INC. |
| K903759 | IRRICLEAR EAR IRRIGATION SYRINGE | Oct 26, 1990 | Unknown | NORTECH LABORATORIES, INC. |
| K900208 | ZEROWET SPLASHIELD | Sep 04, 1990 | Substantially Equivalent | ZEROWET SPLASHIELD |
| K902854 | GRAVITY ASSIST | Aug 29, 1990 | Substantially Equivalent | INSTRUMENT MAKAR, INC. |
| K896800 | IRRIGATION TRAY | May 24, 1990 | Unknown | WESTMARK, STERILE PACKING SYSTEMS, INC. (SPS) |
| K894470 | STRYKER TRAUMA TRAY | Aug 18, 1989 | Substantially Equivalent | STRYKER CORP. |
| K890728 | STERILE IRRIGATION TRAYS | Jun 16, 1989 | Unknown | CYPRESS MEDICAL PRODUCTS, LTD. |
| K884786 | EAR IRRIGATION SET 101 (EARIGATOR) | Apr 26, 1989 | Unknown | PHYSICIANS SUPPLY CO. |
| K884749 | JOHNSON & JOHNSON STERILE SPRAY TIP SYRINGE | Dec 15, 1988 | Substantially Equivalent | JOHNSON & JOHNSON PATIENT CARE, INC. |
| K883506 | IRRIGATION KIT | Dec 13, 1988 | Substantially Equivalent | L H M ENT., INC. |
| K883338 | SURGICAL SEALANT APPLICATOR | Aug 23, 1988 | Substantially Equivalent | MICROMEDICS, INC. |
| K881020 | SURGICAL SEALANT DISPENSER (SSD) | Mar 25, 1988 | Substantially Equivalent | MICROMEDICS, INC. |
| K830572 | CLEAN-FLUSH | Mar 17, 1983 | Substantially Equivalent | BURRON MEDICAL PRODUCTS, INC. |
| K821530 | SYRINGE IRRIGATING | May 28, 1982 | Substantially Equivalent | MEDCARE DISP PRODUCTS, INC. |
| K813027 | STERILE IRRIGATING SYRINGES, KITS,TRAY | Nov 20, 1981 | Substantially Equivalent | WELCON, INC. |
| K810251 | SYRINGE, ENT | Mar 11, 1981 | Substantially Equivalent | MEGAPLAST, INC. |
| K810209 | IRRIJET | Feb 17, 1981 | Substantially Equivalent | ACKRAD LABORATORIES |
| K803200 | IRRIGATION SET W/BULB SYRINGE | Jan 21, 1981 | Substantially Equivalent | WALPAK CO. |
| K801573 | SAPCRILL THERMODETECT BREAST SCANNER DEV | Sep 09, 1980 | Substantially Equivalent | CALIFORNIA CARDIAC SYSTEMS, INC. |
| K791998 | 60CC IRRIGATING SYRINGE, PISTON TYPE, | Oct 26, 1979 | Substantially Equivalent | WAZ INDUSTRIES, INC. |
| K780794 | IRRIGATION CAP | Jul 27, 1978 | Substantially Equivalent | TRAVENOL LABORATORIES, S.A. |
FEI Numbers
This FDA classification entry is associated with 378 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 378 registration numbers. Click on an entry to view related FDA registrations.