510(k) K881020
- Device
- SURGICAL SEALANT DISPENSER (SSD)
- Applicant
- MICROMEDICS, INC.
- 510(k) number
- K881020
- Product code
- KYZ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1988-03-25
- Date received
- 1988-03-10
- 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#
- Contact
- CURT MILLER
- Address
- 268 E. Lafayette Frontage Rd. St. Paul MN US 55107 55107
FDA Registration Numbers#
- 3009104075
- 9710524
- 3010131137
- 2032809
- 1319639
- 8031007
- 1000121056
- 2246990
- 8040233
- 9612030
- 3015277818
- 3009155880
- 1216677
- 3002808270
- 3016267994
- 3015225571
- 3014312726
- 3005841027
- 3008489813
- 2027804
- 3025428426
- 1217805
- 1058726
- 3012507533
- 3031915926
- 1422443
- 3003244954
- 3010288346
- 3012316249
- 2320762
- 3004215929
- 3008719017
- 3005327291
- 3010419931
- 3044026004
- 3006542501
- 1719513
- 3011707784
- 3004519921
- 2183620
- 9680718
- 3015142721
- 3012568936
- 3016676855
- 3021639773
- 3030525551
- 3018074706
- 3015268290
- 3026848699
- 3045058049
- 3016872092
- 8022210
- 9611283
- 1064619
- 3007682555
- 8041151
- 3012002722
- 3014637079
- 3026844237
- 3016851379
- 3010515547
- 3005934752
- 3003965134
- 3038285060
- 3011689956
- 3016884033
- 3010707607
- 2183744
- 3010041511
- 3030178466
- 9680222
- 3010337881
- 3011088743
- 3013506123
- 2183416
- 3012445205
- 3012416077
- 3009742443
- 9680518
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#
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