Laparomed Cholangiogram Vacuum Device
FDA 510(k) K910218 · Laparomed Corp.
510(k) numberK910218
Submission
- Device name
- Laparomed Cholangiogram Vacuum Device
- Applicant
- Laparomed Corp.
Irvine, CA, US - Received
- January 17, 1991
- Decision date
- April 8, 1991
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- GCX – Apparatus, Suction, Operating-Room, Wall Vacuum Powered
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.6740
- Specialty
- General Hospital
Other 510(k)s with product code GCX
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K042454 | Stryker Cassette PumpGCX · Traditional | Stryker Endoscopy | 12/09/2004SE |
| K992126 | Circon Surgiflex Wave Tsunami Suction-Irrigation SystemGCX · Traditional | Circon Corp. | 08/03/1999SE |
| K972074 | Suction InstrumentationGCX · Traditional | Walter Lorenz Surgical, Inc. | 07/25/1997SE |
| K971022 | Chase SuckerGCX · Traditional | Chase Medical, Inc. | 04/17/1997SE |
| K964127 | Medi-Vac Flexi-Clear Suction HandleGCX · Traditional | Allegiance Healthcare Corp. | 12/31/1996SE |
| K964519 | Curity Thoracentesis TrayGCX · Traditional | Kendall Healthcare Products Co. Div.Of Tyco Health | 12/20/1996SE |
| K963648 | Stryker Suction RegulatorGCX · Traditional | Stryker Endoscopy | 11/26/1996SE |
| K962920 | Renton Suction Device U.S. PATENT*4,767,404GCX · Traditional | R&S Surgical, LLC | 10/21/1996SE |
| K961880 | Medcare Suction Connecting TubingGCX · Traditional | Medcare Medical Group, Inc. | 07/19/1996SE |
| K960223 | CPR YankauerGCX · Traditional | Custom Pack Reliability | 03/28/1996SE |
More from Custom Pack Reliability
| 510(k) | Device | Decision |
|---|---|---|
| K934527 | Fascia StitcherGCJ · Traditional | 02/25/1994SE |
| K930569 | Laparomed Laparoscopic Retractor SystemGCJ · Traditional | 04/20/1993SE |
| K921921 | Catheter CholangiographyGEI · Traditional | 08/17/1992SE |
| K921053 | Laparomed Ligating LoopKCJ · Traditional | 08/06/1992SE |
| K921006 | Laparoscopic Retractor SystemGCS · Traditional | 07/28/1992SE |
| K914066 | Electrosurgical Cutting/Coagulation Device/AccessGEI · Traditional | 11/07/1991SE |
| K910074 | Laparomed Hook/Spatula DeviceGEI · Traditional | 07/02/1991SE |
| K910219 | Laparomed Cholangiogram DeviceFGE · Traditional | 04/08/1991SE |
| K905722 | Suture Applier DeviceMFJ · Traditional | 03/14/1991SE |
Questions and answers
When was Laparomed Cholangiogram Vacuum Device cleared by the FDA?
Laparomed Cholangiogram Vacuum Device (K910218) received a 510(k) decision of Substantially Equivalent on April 8, 1991, 81 days after the submission was received.
What is the product code of K910218?
The FDA product code is GCX – Apparatus, Suction, Operating-Room, Wall Vacuum Powered, a Class II (moderate risk) device regulated under 21 CFR 880.6740.