510(k) K831116
- Device
- INVAC W/VARIOUS MODELS
- Applicant
- PMT
- 510(k) number
- K831116
- Product code
- GCX
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1983-08-12
- Date received
- 1983-04-05
- 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
- Alfred A Iversen
- Address
- Box 464 Hopkins MN US 55343 55343
FDA Registration Numbers#
- 2435946
- 1649518
- 3015967359
- 9616088
- 2022724
- 3008624479
- 1018470
- 3049808762
- 3007494890
- 3010396502
- 3003481016
- 2133713
- 1834244
- 3043355002
- 9614209
- 9614434
- 3042940358
- 2011171
- 3007092328
- 2028807
- 3013345545
- 3029917416
- 3012322232
- 3033920060
- 3016601021
- 3016248619
- 1000153536
- 9610531
- 2650143
- 3013557562
- 2936485
- 2320762
- 1054241
- 1924066
- 3004874794
- 1419951
- 3012341425
- 3010834934
- 3042250743
- 3016147813
- 3010041511
- 1526012
- 2028924
- 1423537
- 3005595283
- 3027645317
- 3010966951
- 1034117
- 3008867836
- 3014420084
- 3005515211
- 3007303113
- 1055236
- 3042350604
- 1928237
- 3012445205
- 3013532143
- 3038637162
- 1417592
- 3043747738
- 9610809
- 3022568093
- 3021244152
- 3011137372
- 3018503755
- 3013234390
- 3004111573
- 3010707607
- 3015168845
- 3005440795
- 3013440654
- 2080309
- 1424785
- 1043214
- 1926681
- 8030673
- 1223925
- 3045058049
- 3017540705
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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