GCX — Apparatus, Suction, Operating-Room, Wall Vacuum Powered Class II
FDA product code GCX covers "Apparatus, Suction, Operating-Room, Wall Vacuum Powered", a Class II medical device regulated under 21 CFR 880.6740. Submissions are reviewed by the General Hospital panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- GCX
- Device Class
- Class II
- Regulation Number
- 880.6740
- Submission Type
- Review Panel
- HO
- Medical Specialty
- General Hospital
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K042454 | stryker endoscopy | STRYKER CASSETTE PUMP | December 9, 2004 |
| K992126 | circon | CIRCON SURGIFLEX WAVE TSUNAMI SUCTION-IRRIGATION SYSTEM | August 3, 1999 |
| K972074 | walter lorenz surgical | SUCTION INSTRUMENTATION | July 25, 1997 |
| K971022 | chase medical | CHASE SUCKER | April 17, 1997 |
| K964127 | allegiance healthcare | MEDI-VAC FLEXI-CLEAR SUCTION HANDLE | December 31, 1996 |
| K964519 | kendall healthcare products co. div.of tyco health | CURITY THORACENTESIS TRAY | December 20, 1996 |
| K963648 | stryker endoscopy | STRYKER SUCTION REGULATOR | November 26, 1996 |
| K962920 | r and s surgical | RENTON SUCTION DEVICE U.S. PATENT*4,767,404 | October 21, 1996 |
| K961880 | medcare medical group | MEDCARE SUCTION CONNECTING TUBING | July 19, 1996 |
| K960223 | custom pack reliability | CPR YANKAUER | March 28, 1996 |
| K954869 | medcare custom packaging | MEDCARE YANKAUER SUCTION DEVICE | January 19, 1996 |
| K954726 | stryker endoscopy | STRYKER STRYKEFLOW SUCTION IRRIGATOR (MODIFICATION) | November 29, 1995 |
| K952219 | moore/gobel | SUCTION TIP CLEANER CUP | November 15, 1995 |
| K951119 | american hydro-surgical instruments | NEZHAT-DORSEY SPECIMEN CONTAINER SYSTEM | June 13, 1995 |
| K950464 | sscor | SSCOR/BOARD ..3 MODEL 23000 PRE-ASSEMBLED SUCTION SYSTEM FOR PATIENT TRANSPORT V | April 25, 1995 |
| K931548 | inamed development | INAMED DEVELOPMENT ASPIRATION TIP | January 10, 1994 |
| K924570 | oem medical div | OEM MULTI-VAC POWERED SUCTION PUMP | August 5, 1993 |
| K920912 | medical and environment designs | THE MEDIC TM | July 30, 1993 |
| K924337 | deknatel | PLEUR-EVAC(R) ADULT/PEDI DUAL COLL CHEST DRAIN SYS | July 28, 1993 |
| K924577 | medisonic u.s.a | MEDIVAC | March 23, 1993 |