FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
CONCEPT ARTHROSCOPY RASP
K Number: K862659
·
Decision Sep 2, 1986
Classifications
1
FEI Numbers
76
Registration Numbers
76
Same Product Code
4
Applicant Total
83
Review Days
50
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- CONCEPT ARTHROSCOPY RASP
- K Number
- K862659
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 888.4540
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Applicant
- Concept, Inc.
- Date Received
- July 14, 1986
- Decision Date
- September 2, 1986
- Product Code
- HTP
- Advisory Committee
- Orthopedic
- Review Advisory Committee
- OR
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| HTP | File | FDA class 1 | Orthopedic |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (HTP), ordered by most recent decision date.
INTERMEDICS ORTHOPEDICS REAMERS
FDA 510(k)
FDA Class 1
·Orthopedic
SCHULTZ PHALANGEAL COMP RASP/METACARPAL COMP RASP
FDA 510(k)
FDA Class 1
·Orthopedic
4MM & 5MM FILE
FDA 510(k)
FDA Class 1
·Orthopedic
SUN-LITE BLUE SLIT
FDA 510(k)
FDA Class 1
·Orthopedic
Other Clearances by Concept, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K912640 | CONCEPT ENDOSTEAL FIXATION DEVICE | May 1, 1992 | Substantially Equivalent |
| K912957 | CONCEPT MICROMILL | Oct 4, 1991 | Substantially Equivalent |
| K896648 | CONCEPT UNICOMPARTMENTAL KNEE SYSTEM | Jun 5, 1990 | Substantially Equivalent for Some Indications |
| K894929 | STAPLE FIXATION SYSTEM | Aug 30, 1989 | Substantially Equivalent |
| K892376 | INTRAVISION(TM) ARTHROSCOPE SYSTEM (ADD'L APPLI.) | Aug 1, 1989 | Substantially Equivalent |
| K891109 | PANDA(R) NEEDLE CATHETER JEJUNOSTOMY TUBE | May 8, 1989 | Substantially Equivalent |
| K881954 | CONCEPT POWER SYSTEM | Nov 9, 1988 | Substantially Equivalent |
| K884255 | CONCEPT CCT-5200, THERMAL THERAPY SYSTEM | Nov 8, 1988 | Substantially Equivalent |
| K882121 | C-FLO SUCTION TUBE | Jun 20, 1988 | Substantially Equivalent |
| K880414 | TENDON HARVESTER | Mar 25, 1988 | Substantially Equivalent |