Concept Switching Stick
FDA 510(k) K873009 · Concept, Inc.
510(k) numberK873009
Submission
- Device name
- Concept Switching Stick
- Applicant
- Concept, Inc.
Clearwater, FL, US - Received
- August 4, 1987
- Decision date
- August 17, 1987
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- KGZ – Accessories, Catheter
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 878.4200
- Specialty
- General, Plastic Surgery
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| K973183 | Wound Drainage HolderKGZ · Traditional | R & D Medical Products, Inc. | 01/23/1998SE |
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| K896087 | Palestrant Irrigation and Drainage SetKGZ · Traditional | North American Instrument Corp. | 11/03/1989SE |
| K895041 | Optical Catheter(Tm) Introducer SetsKGZ · Traditional | Medical Dynamics, Inc. | 10/16/1989SE |
| K893406 | Deseret PRN AdapterKGZ · Traditional | Deseret Medical, Inc. | 06/22/1989SE |
| K870014 | Hci General Purpose Catheter StyletKGZ · Traditional | Health Care Innovations, Inc. | 02/06/1987SE |
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More from Cathaid, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K912640 | Concept Endosteal Fixation DeviceHWC · Traditional | 05/01/1992SE |
| K912957 | Concept MicromillHRX · Traditional | 10/04/1991SE |
| K896648 | Concept Unicompartmental Knee SystemHSX · Traditional | 06/05/1990SN |
| K894929 | Staple Fixation SystemJDR · Traditional | 08/30/1989SE |
| K892376 | Intravision(Tm) Arthroscope System (Add'L Appli.)HRX · Traditional | 08/01/1989SE |
| K891109 | Panda(R) Needle Catheter Jejunostomy TubeKNT · Traditional | 05/08/1989SE |
| K881954 | Concept Power SystemHSZ · Traditional | 11/09/1988SE |
| K884255 | Concept CCT-5200, Thermal Therapy SystemILO · Traditional | 11/08/1988SE |
| K882121 | C-Flo Suction TubeDXQ · Traditional | 06/20/1988SE |
| K880414 | Tendon HarvesterHRX · Traditional | 03/25/1988SE |
Questions and answers
When was Concept Switching Stick cleared by the FDA?
Concept Switching Stick (K873009) received a 510(k) decision of Substantially Equivalent on August 17, 1987, 13 days after the submission was received.
What is the product code of K873009?
The FDA product code is KGZ – Accessories, Catheter, a Class I (low risk) device regulated under 21 CFR 878.4200.