510(k) K911238
- Device
- TAHOE SUCTION IRRIGATOR
- Applicant
- TAHOE PRO INSTRUMENTS
- 510(k) number
- K911238
- Product code
- GCX
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1992-11-27
- Date received
- 1991-03-20
- Regulation
- 880.6740
- Classification name
- Apparatus, Suction, Operating-room, Wall Vacuum Powered
- Medical specialty
- General Hospital
- Review panel
- General Hospital
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- GARY WILLEN
- Address
- P.O. Box 612617 So. Lake Tahoe CA US 95761 95761
FDA Registration Numbers#
- 1319211
- 2936485
- 3007829657
- 1057421
- 3013735622
- 3010041511
- 3012447612
- 3016426850
- 2435946
- 2650143
- 3007649127
- 2016945
- 3010373530
- 9610809
- 3008114965
- 9617744
- 8010273
- 3007092328
- 3012322232
- 2518417
- 3016601021
- 3004137296
- 8030673
- 3043355002
- 1032347
- 1219659
- 3006395447
- 3030979378
- 9610531
- 2649614
- 2080309
- 3005440795
- 3013557562
- 3017635043
- 1643817
- 3011137372
- 3018503755
- 3010707607
- 1526439
- 9610617
- 2640138
- 3010131137
- 3045058049
- 1054241
- 3015168845
- 3042250743
- 3014656668
- 1921846
- 2032476
- 3008797953
- 1818910
- 3015978022
- 2028924
- 3008688054
- 1419951
- 2133713
- 1055236
- 3007303113
- 3013234390
- 3017540705
- 1424263
- 1048735
- 3042350604
- 3006897996
- 3042940358
- 2916714
- 3030516433
- 3003485902
- 9616088
- 3008867836
- 3016050940
- 1422634
- 3016248619
- 1047843
- 3013532143
- 3004111573
- 3007494890
- 3005515211
- 3006606984
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code GCX #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K042454 | STRYKER CASSETTE PUMP | Stryker Endoscopy | 2004-12-09 |
| K992126 | CIRCON SURGIFLEX WAVE TSUNAMI SUCTION-IRRIGATION SYSTEM | Circon Corp. | 1999-08-03 |
| K972074 | SUCTION INSTRUMENTATION | Walter Lorenz Surgical, Inc. | 1997-07-25 |
| K971022 | CHASE SUCKER | Chase Medical, Inc. | 1997-04-17 |
| K964127 | MEDI-VAC FLEXI-CLEAR SUCTION HANDLE | Allegiance Healthcare Corp. | 1996-12-31 |
| K964519 | CURITY THORACENTESIS TRAY | Kendall Healthcare Products Co. Div.Of Tyco Health | 1996-12-20 |
| K963648 | STRYKER SUCTION REGULATOR | Stryker Endoscopy | 1996-11-26 |
| K962920 | RENTON SUCTION DEVICE U.S. PATENT*4,767,404 | R&S Surgical, LLC | 1996-10-21 |
| K961880 | MEDCARE SUCTION CONNECTING TUBING | Medcare Medical Group, Inc. | 1996-07-19 |
| K960223 | CPR YANKAUER | Custom Pack Reliability | 1996-03-28 |
| K954869 | MEDCARE YANKAUER SUCTION DEVICE | Medcare Custom Packaging, Inc. | 1996-01-19 |
| K954726 | STRYKER STRYKEFLOW SUCTION IRRIGATOR (MODIFICATION) | Stryker Endoscopy | 1995-11-29 |
| K952219 | SUCTION TIP CLEANER CUP | Moore/Gobel | 1995-11-15 |
| K951119 | NEZHAT-DORSEY SPECIMEN CONTAINER SYSTEM | American Hydro-Surgical Instruments, Inc. | 1995-06-13 |
| K950464 | SSCOR/BOARD ..3 MODEL 23000 PRE-ASSEMBLED SUCTION SYSTEM FOR PATIENT TRANSPORT VEHICLES | Sscor | 1995-04-25 |
Legacy Summary#
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FDA Review#
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