Curity Thoracentesis Tray
FDA 510(k) K964519 · Kendall Healthcare Products Co. Div.Of Tyco Health
510(k) numberK964519
Submission
- Device name
- Curity Thoracentesis Tray
- Applicant
- Kendall Healthcare Products Co. Div.Of Tyco Health
Mansfield, MA, US - Received
- November 12, 1996
- Decision date
- December 20, 1996
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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 |
| 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 |
| K954869 | Medcare Yankauer Suction DeviceGCX · Traditional | Medcare Custom Packaging, Inc. | 01/19/1996SE |
More from Medcare Custom Packaging, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K973763 | Kendall Curity Iodoform Packing StripEFQ · Traditional | 12/31/1997SE |
| K973511 | Kendall Curity Petrolatum GauzeFRO · Traditional | 12/16/1997SN |
| K973507 | Kendall Xeroform Petrolatum Dressing (6311,6312,6313,6314,6315,6316,6317)FRO · Traditional | 12/15/1997SN |
| K973619 | Kendall Curity Non-Adhering DressingKMF · Traditional | 12/10/1997SN |
| K973509 | Kendall Curasorb ZN + MG Alginate Wound DressingKMF · Traditional | 12/04/1997SN |
| K973546 | Kendall Fast-Cath Pre Lubricated Urethral CatheterEZD · Traditional | 11/07/1997SE |
| K970266 | Kendall Hydrophilic Powder Wound DressingKGN · Traditional | 04/23/1997SN |
| K963446 | Kendall Dual Lumen CatheterMPB · Traditional | 03/18/1997SE |
| K964899 | Kendall Curity Ureteral CatheterEYB · Traditional | 02/07/1997SE |
| K961977 | Kendall Sher-I-Bronch Endobrochial TubeCBI · Traditional | 07/31/1996SE |
Questions and answers
When was Curity Thoracentesis Tray cleared by the FDA?
Curity Thoracentesis Tray (K964519) received a 510(k) decision of Substantially Equivalent on December 20, 1996, 38 days after the submission was received.
What is the product code of K964519?
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.