GCX · Apparatus, Suction, Operating-Room, Wall Vacuum Powered
General Hospital · 21 CFR 880.6740 · Class 2
Overview
| Product Code | GCX |
|---|---|
| Device Name | Apparatus, Suction, Operating-Room, Wall Vacuum Powered |
| Regulation | 21 CFR 880.6740 |
| Device Class | Class 2 |
| Review Panel | General Hospital |
Identification
A vacuum-powered body fluid suction apparatus is a device used to aspirate, remove, or sample body fluids. The device is powered by an external source of vacuum. This generic type of device includes vacuum regulators, vacuum collection bottles, suction catheters and tips, connecting flexible aspirating tubes, rigid suction tips, specimen traps, noninvasive tubing, and suction regulators (with gauge).
Classification Rationale
Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 880.9.
Special Controls
*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 880.9.
Recent Cleared Devices (20 of 87)
Showing 20 most recent of 87 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K042454 | STRYKER CASSETTE PUMP | Stryker Endoscopy | Dec 9, 2004 | SESE |
| K992126 | CIRCON SURGIFLEX WAVE TSUNAMI SUCTION-IRRIGATION SYSTEM | Circon Corp. | Aug 3, 1999 | SESE |
| K972074 | SUCTION INSTRUMENTATION | Walter Lorenz Surgical, Inc. | Jul 25, 1997 | SESE |
| K971022 | CHASE SUCKER | Chase Medical, Inc. | Apr 17, 1997 | SESE |
| K964127 | MEDI-VAC FLEXI-CLEAR SUCTION HANDLE | Allegiance Healthcare Corp. | Dec 31, 1996 | SESE |
| K964519 | CURITY THORACENTESIS TRAY | Kendall Healthcare Products Co. Div.Of Tyco Health | Dec 20, 1996 | SESE |
| K963648 | STRYKER SUCTION REGULATOR | Stryker Endoscopy | Nov 26, 1996 | SESE |
| K962920 | RENTON SUCTION DEVICE U.S. PATENT*4,767,404 | R&S Surgical, LLC | Oct 21, 1996 | SESE |
| K961880 | MEDCARE SUCTION CONNECTING TUBING | Medcare Medical Group, Inc. | Jul 19, 1996 | SESE |
| K960223 | CPR YANKAUER | Custom Pack Reliability | Mar 28, 1996 | SESE |
| K954869 | MEDCARE YANKAUER SUCTION DEVICE | Medcare Custom Packaging, Inc. | Jan 19, 1996 | SESE |
| K954726 | STRYKER STRYKEFLOW SUCTION IRRIGATOR (MODIFICATION) | Stryker Endoscopy | Nov 29, 1995 | SESE |
| K952219 | SUCTION TIP CLEANER CUP | Moore/Gobel | Nov 15, 1995 | SESE |
| K951119 | NEZHAT-DORSEY SPECIMEN CONTAINER SYSTEM | American Hydro-Surgical Instruments, Inc. | Jun 13, 1995 | SESE |
| K950464 | SSCOR/BOARD ..3 MODEL 23000 PRE-ASSEMBLED SUCTION SYSTEM FOR PATIENT TRANSPORT VEHICLES | Sscor | Apr 25, 1995 | SESE |
| K931548 | INAMED DEVELOPMENT ASPIRATION TIP | Inamed Development Co. | Jan 10, 1994 | SESE |
| K924570 | OEM MULTI-VAC POWERED SUCTION PUMP | Oem Medical Div. | Aug 5, 1993 | SESE |
| K920912 | THE MEDIC TM | Medical and Environment Designs, Inc. | Jul 30, 1993 | SESE |
| K924337 | PLEUR-EVAC(R) ADULT/PEDI DUAL COLL CHEST DRAIN SYS | Deknatel, Inc. | Jul 28, 1993 | SESE |
| K924577 | MEDIVAC | Medisonic U.S.A., Inc. | Mar 23, 1993 | SESE |
Top Applicants
- Westmark, Sterile Packing Systems, Inc. (Sps) — 6 clearances
- Deknatel, Inc. — 4 clearances
- Sherwood Medical Co. — 3 clearances
- Sherwood Medical Industries — 3 clearances
- Sorensen Research — 3 clearances
