Concept Arthroscopy Rasp
FDA 510(k) K862659 · Concept, Inc.
510(k) numberK862659
Submission
- Device name
- Concept Arthroscopy Rasp
- Applicant
- Concept, Inc.
Clearwater, FL, US - Received
- July 14, 1986
- Decision date
- September 2, 1986
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- HTP – File
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 888.4540
- Specialty
- Orthopedic
Other 510(k)s with product code HTP
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K931733 | Intermedics Orthopedics ReamersHTP · Traditional | Intermedics Orthopedics | 01/26/1994SE |
| K870842 | Schultz Phalangeal Comp Rasp/Metacarpal Comp RaspHTP · Traditional | Warsaw Orthopedic, Inc. | 05/27/1987SE |
| K841981 | 4MM & 5MM FileHTP · Traditional | Stainless Mfg., Inc. | 06/19/1984SE |
| K840492 | Sun-Lite Blue SlitHTP · Traditional | Suncoast Medical Manufacturers, Inc. | 05/09/1984SE |
More from Suncoast Medical Manufacturers, 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 Arthroscopy Rasp cleared by the FDA?
Concept Arthroscopy Rasp (K862659) received a 510(k) decision of Substantially Equivalent on September 2, 1986, 50 days after the submission was received.
What is the product code of K862659?
The FDA product code is HTP – File, a Class I (low risk) device regulated under 21 CFR 888.4540.