Adair/Veress Needle Introducer Set
FDA 510(k) K930568 · Medical Dynamics, Inc.
510(k) numberK930568
Submission
- Device name
- Adair/Veress Needle Introducer Set
- Applicant
- Medical Dynamics, Inc.
Englewood, CO, US - Received
- January 26, 1993
- Decision date
- July 22, 1993
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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 |
| 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 |
| K780896 | Needles, Design Change, IV CathetersGCB · Traditional | Jelco Laboratories | 08/23/1978SE |
More from Jelco Laboratories
| 510(k) | Device | Decision |
|---|---|---|
| K974542 | True Vision, True Vision IIEIA · Traditional | 02/17/1998SE |
| K921294 | Video Endoscope-Rigid ModificationHET · Traditional | 07/20/1994SE |
| K934682 | Surgical Video Camera and AccessoriesFWF · Traditional | 02/15/1994SE |
| K915538 | Over the Wire Stone BasketLQR · Traditional | 03/20/1992SE |
| K914315 | Optical Catheter Introducer Sets, ModificationKGX · Traditional | 03/04/1992SE |
| K913986 | Cholangiography/Cholangioscopy/Lihopaxy SystemFGE · Traditional | 01/28/1992SESK |
| K911296 | Optical Catheter ArthroscopeHRX · Traditional | 09/24/1991SE |
| K903339 | Video Endoscope, RigidHET · Traditional | 03/06/1991SE |
| K904609 | Xenon Light SourceHBI · Traditional | 12/18/1990SE |
| K904113 | Operative Recording CameraIKO · Traditional | 10/30/1990SE |
Questions and answers
When was Adair/Veress Needle Introducer Set cleared by the FDA?
Adair/Veress Needle Introducer Set (K930568) received a 510(k) decision of Substantially Equivalent on July 22, 1993, 177 days after the submission was received.
What is the product code of K930568?
The FDA product code is GCB – Needle, Catheter, a Class I (low risk) device regulated under 21 CFR 878.4200.