510(k) K992126
- Device
- CIRCON SURGIFLEX WAVE TSUNAMI SUCTION-IRRIGATION SYSTEM
- Applicant
- CIRCON CORP.
- 510(k) number
- K992126
- Product code
- GCX
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1999-08-03
- Date received
- 1999-06-23
- 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
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- RONALD J EHMSEN
- Address
- 6500 Hollister Ave. Santa Barbara CA US 93117 93117
FDA Registration Numbers#
- 3022568093
- 3005440795
- 3017751928
- 2649614
- 3016248619
- 3030516433
- 3005595283
- 9610617
- 3012445205
- 3027645317
- 3015967359
- 1526711
- 3042940358
- 3004839227
- 2011171
- 9612030
- 1061124
- 3010041511
- 3018074706
- 2028924
- 3005515211
- 3016601021
- 3010170586
- 9611827
- 3008797953
- 3007681502
- 2640138
- 2433012
- 3015168845
- 3016147813
- 3010131137
- 8030673
- 1623486
- 1314417
- 3004111573
- 1034117
- 2648666
- 2320762
- 2133713
- 3029917416
- 1054241
- 1219659
- 3010707607
- 3007494890
- 3002732769
- 3005273623
- 3008624479
- 3043747738
- 1032347
- 9614209
- 3017540705
- 2032476
- 3004491689
- 3004096300
- 3016426850
- 3014420084
- 3013532143
- 3010966951
- 3005669815
- 1928237
- 3017635043
- 3027977504
- 1223925
- 1319639
- 1526439
- 3012322232
- 3012075008
- 3021284283
- 1424263
- 1018470
- 1043214
- 1423395
- 2529846
- 1319211
- 3033920060
- 3007649127
- 3008867836
- 3024787345
- 3004137296
Source Documents#
Other 510(k) Records For Product Code GCX #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K042454 | STRYKER CASSETTE PUMP | Stryker Endoscopy | 2004-12-09 |
| 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 |
| K931548 | INAMED DEVELOPMENT ASPIRATION TIP | Inamed Development Co. | 1994-01-10 |
Legacy Summary#
summary
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