Needles, Design Change, IV Catheters
FDA 510(k) K780896 · Jelco Laboratories
510(k) numberK780896
Submission
- Device name
- Needles, Design Change, IV Catheters
- Applicant
- Jelco Laboratories
- Received
- May 30, 1978
- Decision date
- August 23, 1978
- 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 |
| K854327 | Subcutaneous Tunneling Needles & HandlesGCB · Traditional | Concord Laboratories, Inc. | 11/13/1985SE |
| K852428 | Manan Epidural NeedleGCB · Traditional | Manan Manufacturing Co., Inc. | 06/27/1985SE |
More from Manan Manufacturing Co., Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K791918 | Jelco Winged Intravascular CatheterFOZ · Traditional | 10/02/1979SE |
| K791372 | Jelco & Kvo Catheter Placement UnitJCY · Traditional | 09/12/1979SE |
| K790967 | Catheter Metal Hub/RadiopaqueFOZ · Traditional | 06/27/1979SE |
| K790968 | Catheter Metal Hub/NonradiopaqueFOZ · Traditional | 06/11/1979SE |
| K790471 | Jelco* Disc FILTER-0.2 MicronFPB · Traditional | 04/30/1979SE |
| K790186 | ProtectivstabilizerGBJ · Traditional | 02/26/1979SE |
| K790107 | Catheter Tubing ModificationDQO · Traditional | 02/01/1979SE |
| K790079 | Needle, Blood CollectingGAA · Traditional | 02/01/1979SE |
| K781857 | Tray, Arterial Blood Gas SamplingCBT · Traditional | 12/11/1978SE |
| K780519 | Filter TubeBSN · Traditional | 05/09/1978SE |
Questions and answers
When was Needles, Design Change, IV Catheters cleared by the FDA?
Needles, Design Change, IV Catheters (K780896) received a 510(k) decision of Substantially Equivalent on August 23, 1978, 85 days after the submission was received.
What is the product code of K780896?
The FDA product code is GCB – Needle, Catheter, a Class I (low risk) device regulated under 21 CFR 878.4200.