510(k) K962920
- Device
- Renton Suction Device U.s. Patent*4,767,404
- Applicant
- R&S SURGICAL, LLC.
- 510(k) number
- K962920
- Product code
- GCX
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1996-10-21
- Date received
- 1996-07-26
- 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
- Statement or summary
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- DERRIC RENTON
- Address
- 107 Tunnel Hill Rd. Georgetown IN US 47122 47122
FDA Registration Numbers#
- 3010131137
- 9616088
- 3014388471
- 1061124
- 9614434
- 2080309
- 3010155661
- 1032347
- 3045058049
- 3043747738
- 1818910
- 3016248619
- 9610531
- 3010170586
- 3043355002
- 1424263
- 3012075008
- 8030673
- 2020550
- 9614209
- 3011137372
- 2936485
- 3010707607
- 3004874794
- 3010202439
- 3005587132
- 3011182134
- 3018074706
- 3007305485
- 1057421
- 2133713
- 3030516433
- 3007494890
- 3017751928
- 9610809
- 1924066
- 9610632
- 3008264111
- 3008114965
- 3007681502
- 9610617
- 3016426850
- 2011171
- 1034117
- 3027977504
- 3003481016
- 3013440654
- 3013735622
- 3011198121
- 1417592
- 3012447612
- 3005987240
- 3030979378
- 3008867836
- 3010966951
- 3029917416
- 2435946
- 3014926389
- 1649518
- 1000153536
- 3017635043
- 3004839227
- 3010221586
- 3004438577
- 2032112
- 9612030
- 3024787345
- 3007303113
- 3013530901
- 3013557562
- 3012322232
- 3002732769
- 3010041511
- 1928237
- 3007649127
- 3014420084
- 3004476158
- 3023809973
- 3017406698
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 |
| 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 |
| K931548 | INAMED DEVELOPMENT ASPIRATION TIP | Inamed Development Co. | 1994-01-10 |