FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
MULTIPLE MANUAL SURGICAL INSTRUMENTS
K Number: K832686
·
Decision Oct 14, 1983
Classifications
1
FEI Numbers
354
Registration Numbers
354
Same Product Code
13
Applicant Total
8
Review Days
73
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Basic Information
- Device Name
- MULTIPLE MANUAL SURGICAL INSTRUMENTS
- K Number
- K832686
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 888.4540
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Applicant
- Hirata Sangyo Co. USA, Inc.
- Date Received
- August 2, 1983
- Decision Date
- October 14, 1983
- Product Code
- HTO
- 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 |
|---|---|---|---|
| HTO | Reamer | FDA class 1 | Orthopedic |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (HTO), ordered by most recent decision date.
SYNTHES RIA SYSTEM (EXPANDED INDICATIONS)
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SYNTHES (USA) RIA SYSTEM - EXPANDED INDICATIONS
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MODIFICATION TO SYNTHES (USA) REAMER IRRIGATOR ASPIRATOR (RIA) SYSTEM
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SYNTHES REAMER/IRRIGATOR/ASPIRATOR (RIA) SYSTEM
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FLEXIBLE INTRAMEDULLARY REAMER
FDA 510(k)
FDA Class 1
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COMBINATION REAMER
FDA 510(k)
FDA Class 1
·Orthopedic
Other Clearances by Hirata Sangyo Co. USA, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K864106 | SR-MODEL 230 (MODIFICATION) | Nov 19, 1986 | Substantially Equivalent |
| K842289 | SR- MODEL 230 | Jul 25, 1984 | Substantially Equivalent |
| K833541 | SURGICAL INSTRUMENT | Nov 28, 1983 | Substantially Equivalent |
| K833542 | SURGICAL INSTRUMENT | Nov 28, 1983 | Substantially Equivalent |
| K831583 | GP-303 | Jul 19, 1983 | Substantially Equivalent |
| K821989 | NON-STETHO 7, UM-15TP | Oct 18, 1982 | Substantially Equivalent |
| K822571 | SYRINGE PUMP | Oct 8, 1982 | Substantially Equivalent |