510(k) K813394
- Device
- DS-7 CLOSED WOUND SUCTION DRAIN SYSTEM
- Applicant
- COX-UPHUFF INTL.
- 510(k) number
- K813394
- Product code
- GCX
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1982-01-22
- Date received
- 1981-12-04
- 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#
- Address
- 4221 Richmond Rd., NW Walker MI US 49534 49534
FDA Registration Numbers#
- 3016050940
- 1422634
- 1314417
- 3012341425
- 3003902312
- 3007829657
- 3010396502
- 3014388471
- 3038637162
- 2020550
- 1223925
- 9617744
- 1424785
- 3004874794
- 1834244
- 2936485
- 3002732769
- 3010170586
- 3011182134
- 3008264111
- 3017540705
- 2032112
- 3007303113
- 3020796687
- 3004476158
- 1526012
- 2518417
- 3011422544
- 1017294
- 3004365956
- 3007203968
- 2244478
- 8010273
- 3005440795
- 3027977504
- 3014421917
- 3030558088
- 3016080683
- 1048735
- 2022724
- 2529846
- 9610809
- 9611018
- 1000523114
- 3006606984
- 1649518
- 1032347
- 3010221586
- 9614434
- 3043355002
- 3008624479
- 1054241
- 3004839227
- 1713468
- 3009888344
- 3010155661
- 2032476
- 1047843
- 3013234390
- 3018503755
- 1526439
- 3022568093
- 3012445205
- 2650143
- 9680260
- 1423395
- 3010966951
- 9616088
- 1018470
- 3021284283
- 3016601021
- 3013345545
- 2080309
- 3012447612
- 9611500
- 2016945
- 3017751928
- 2435946
- 2433012
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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