510(k) K810251
- Device
- SYRINGE, ENT
- Applicant
- MEGAPLAST, INC.
- 510(k) number
- K810251
- Product code
- KYZ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1981-03-11
- Date received
- 1981-01-29
- 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#
- 3014570560
- 3010337881
- 1066368
- 3008824097
- 3003887292
- 3002579136
- 3006610790
- 3011707784
- 3005593675
- 3013497020
- 3005987240
- 3007583964
- 3006950086
- 3003169405
- 3011137372
- 3015967359
- 3009155880
- 1317900
- 3011182134
- 3016872092
- 3018781093
- 1721504
- 3005034064
- 3024999438
- 2032809
- 1058726
- 9611102
- 3005669815
- 3016884033
- 1820334
- 2320762
- 1720929
- 1526854
- 3004361445
- 3004001706
- 3005448067
- 1043646
- 3013764800
- 8040179
- 3044026004
- 3013443304
- 3005515211
- 3010626066
- 3004468406
- 3005271071
- 9680222
- 3010889742
- 9680718
- 3003965134
- 3003877407
- 3017636737
- 1423537
- 1450662
- 3004550973
- 3038285060
- 8010730
- 9614062
- 3004111573
- 1055236
- 2648727
- 3017618922
- 3030447506
- 3012494290
- 9611503
- 3042367543
- 1061124
- 3015238043
- 1417592
- 8043685
- 3013506123
- 9680794
- 9610617
- 3010707607
- 3009308092
- 9612030
- 3006536657
- 8010418
- 3005670221
- 3008412545
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