510(k) K821841
- Device
- MEDIGAS SUCTION/DRAINAGE EQUIPMENT
- Applicant
- LINDE DIV. UNION CARBIDE CORP.
- 510(k) number
- K821841
- Product code
- GCX
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1982-07-02
- Date received
- 1982-06-22
- 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
- 803 N. Front St. Suite 3 Mchenry IL US 60050 60050
FDA Registration Numbers#
- 3023809973
- 1417592
- 3007092328
- 3001104093
- 1526711
- 9612030
- 3004491689
- 1314417
- 2029275
- 3004111573
- 3010041511
- 3005669815
- 2518417
- 1423395
- 3012447612
- 3018074706
- 2648623
- 3017540705
- 3013735622
- 3005515211
- 3004365956
- 1000153536
- 1643817
- 3007305485
- 3012322232
- 1048735
- 1223925
- 2936485
- 3006897996
- 3003620648
- 3022568093
- 1526439
- 3016426850
- 3006395447
- 9610531
- 9610809
- 3007829657
- 3010373530
- 1319211
- 9614209
- 3042940358
- 1713468
- 3013532143
- 3020796687
- 9611827
- 3003481016
- 3004137296
- 1834244
- 3010202439
- 1924066
- 9610612
- 3004874794
- 1034117
- 1424263
- 1424785
- 9617744
- 3005528784
- 2080309
- 3014342096
- 3007649127
- 3029917416
- 3004096300
- 9616088
- 3024787345
- 2133713
- 3011422544
- 3008624479
- 3011137372
- 1649518
- 1000523114
- 3011182134
- 3017751928
- 3004438577
- 3045077467
- 1032347
- 2916714
- 3003674698
- 2435946
- 8030673
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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