510(k) K813027
- Device
- STERILE IRRIGATING SYRINGES, KITS,TRAY
- Applicant
- WELCON, INC.
- 510(k) number
- K813027
- Product code
- KYZ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1981-11-20
- Date received
- 1981-10-28
- Regulation
- 880.6960
- Classification name
- Syringe, Irrigating (non Dental)
- Medical specialty
- General Hospital
- Review panel
- General Hospital
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Address
- 803 N. Front St. Suite 3 Mchenry IL US 60050 60050
FDA Registration Numbers#
- 3003244954
- 3003965134
- 3013247477
- 3003799587
- 9680411
- 9710020
- 1314417
- 3013057712
- 3031231776
- 3004111573
- 3033589330
- 3010626066
- 3044026004
- 2183425
- 3010400367
- 9611503
- 3015268290
- 3016734024
- 3008936260
- 2523676
- 2530138
- 9610825
- 3005515211
- 1423625
- 8040233
- 3009499159
- 3005998497
- 3016660845
- 3004361445
- 2220100
- 8043816
- 3014615697
- 3036722184
- 3009155880
- 3012507533
- 3002808270
- 1035907
- 3009746061
- 8040179
- 3031915926
- 3015309643
- 3016872092
- 3043051314
- 3031184338
- 3006542380
- 3011805315
- 3007060769
- 3005809810
- 1824619
- 1043214
- 1043646
- 3007456622
- 3008719222
- 3024088964
- 3006610790
- 3035642068
- 1317900
- 1047843
- 3007682555
- 1000393132
- 3006730167
- 1064858
- 1423537
- 3012568936
- 3018116884
- 1911916
- 9680518
- 2029275
- 3012445205
- 3008489813
- 1054241
- 3006973666
- 3014579161
- 3008693658
- 1210513
- 9610621
- 2020550
- 3013506123
- 3011209790
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code KYZ #
| 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 |
| K952406 | REDI NURSE SYSTEM (RNS) PRE-FILLED 60CC IRRIGATION SYRINGE W/STERILE SODIUM CHLORIDE SOLUTION | Contour Fabricators of Florida, Inc. | 1995-08-07 |
| K952407 | REDI NURSE SYSTEM (RNS) PRE-FILLED 10CC, 30CC, 60CC SYRINGE W/STERILE WATER | 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 |
Legacy Summary#
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FDA Review#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases