Subcutaneous Tunneling Needles & Handles
FDA 510(k) K854327 · Concord Laboratories, Inc.
510(k) numberK854327
Submission
- Device name
- Subcutaneous Tunneling Needles & Handles
- Applicant
- Concord Laboratories, Inc.
Keene, NH, US - Received
- October 28, 1985
- Decision date
- November 13, 1985
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- GCB – Needle, Catheter
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 878.4200
- Specialty
- General, Plastic Surgery
Other 510(k)s with product code GCB
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K150800 | Valved Safety Centesis CatheterGCB · Traditional | B.Braun Medical, Inc. | 11/12/2015SE |
| K974146 | Paracentesis Catheter DeviceGCB · Traditional | Allegiance Healthcare Corp. | 01/28/1998SE |
| K930568 | Adair/Veress Needle Introducer SetGCB · Traditional | Medical Dynamics, Inc. | 07/22/1993SE |
| K923028 | Turkel Pneumothorax KitGCB · Traditional | Symbiosis Corp. | 08/04/1992SE |
| K900374 | Adair/Veress Needle Introducer SetGCB · Traditional | Medical Dynamics, Inc. | 04/20/1990SE |
| K852428 | Manan Epidural NeedleGCB · Traditional | Manan Manufacturing Co., Inc. | 06/27/1985SE |
| K780896 | Needles, Design Change, IV CathetersGCB · Traditional | Jelco Laboratories | 08/23/1978SE |
More from Jelco Laboratories
| 510(k) | Device | Decision |
|---|---|---|
| K883840 | Dri-Vent Arterial Blood Sampling KitLKB · Traditional | 05/16/1989SESD |
| K871825 | Meconium Suction CatheterBSY · Traditional | 06/29/1987SE |
| K864535 | Tracheobronchial Suction Catheter, Cat. No. 6110BSY · Traditional | 01/06/1987SE |
| K862039 | Concord Care Tray · Traditional | 07/03/1986SESD |
| K854601 | Spring Guide Catheter Anesthesia Conduction CathBSO · Traditional | 01/10/1986SE |
| K851134 | Regional Anesthesia TraysCAZ · Traditional | 07/15/1985SESD |
| K842095 | Epidural TraysCAZ · Traditional | 07/03/1984SE |
| K841486 | Arterial Blood Sampling KitsCBT · Traditional | 05/23/1984SE |
| K840987 | Vaporized HeparinCBT · Traditional | 04/05/1984SE |
| K840986 | Prefilled Pulsator SyringeCBT · Traditional | 04/05/1984SE |
Questions and answers
When was Subcutaneous Tunneling Needles & Handles cleared by the FDA?
Subcutaneous Tunneling Needles & Handles (K854327) received a 510(k) decision of Substantially Equivalent on November 13, 1985, 16 days after the submission was received.
What is the product code of K854327?
The FDA product code is GCB – Needle, Catheter, a Class I (low risk) device regulated under 21 CFR 878.4200.