510(k) K102563
- Device
- SINGLE CANNULA EXTENDED APPLICATOR
- Applicant
- MICROMEDICS, INC.
- 510(k) number
- K102563
- Product code
- KYZ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2011-03-15
- Date received
- 2010-09-07
- Regulation
- 880.6960
- Classification name
- Syringe, Irrigating (non Dental)
- Medical specialty
- General Hospital
- Review panel
- General Hospital
- Device class
- 1
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- TOM LOPAC
- Address
- 1270 Eagan Industrial Rd. St. Paul MN US 55121 55121
FDA Registration Numbers#
- 3005099803
- 9710524
- 1047843
- 3016267994
- 3013298431
- 3003418325
- 3023855650
- 3034667025
- 1721504
- 3044026004
- 3011460807
- 3009746061
- 3014342096
- 1319639
- 3007137643
- 3017907716
- 3012416077
- 3012445205
- 9680518
- 3015142721
- 3006157842
- 3008280537
- 3016734024
- 1066368
- 3006181312
- 3012314549
- 1058726
- 1287329
- 1062671
- 3014615697
- 3009499159
- 1643817
- 3011805315
- 9710641
- 9710020
- 9613083
- 3004941127
- 3016676855
- 9680718
- 3027520350
- 3009307523
- 3003799587
- 1911916
- 3025428426
- 3005841027
- 1820334
- 9681260
- 3005245797
- 3042200051
- 3017618922
- 3005273623
- 3003902312
- 3020468145
- 1928237
- 3010131137
- 8010730
- 3010419931
- 9680222
- 1037752
- 3025337868
- 3010621964
- 1720929
- 3011707784
- 3012002722
- 3010594263
- 3007456622
- 3015238043
- 3031233007
- 1417592
- 3038285060
- 1416980
- 3007963782
- 3038294399
- 8043685
- 3008427684
- 3041276591
- 3007125392
- 3012421607
- 1061124
- 9610617
Source Documents#
Other 510(k) Records For Product Code KYZ #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K201877 | OtoSet- Ear Cleaning System | Safkan, Inc. | 2020-11-05 |
| 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 |
| K924517 | AVITENE DISPENSER SYRINGE | Nusurg, Inc. | 1993-10-27 |
Legacy Summary#
summary
FDA Review#
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