FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
FMS DUO
K Number: K954465
·
Decision Nov 9, 1995
Classifications
1
FEI Numbers
386
Registration Numbers
386
Same Product Code
680
Applicant Total
12
Review Days
45
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Basic Information
- Device Name
- FMS DUO
- K Number
- K954465
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.1100
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Future Medical Systems, Inc.
- Date Received
- September 25, 1995
- Decision Date
- November 9, 1995
- Product Code
- HRX
- 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 |
|---|---|---|---|
| HRX | Arthroscope | FDA class 2 | Orthopedic |
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Other Clearances by Future Medical Systems, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K023963 | ADHOC CLAW | May 5, 2003 | Substantially Equivalent |
| K021030 | TITANIUM CANNULATED INTERFERENCE SCREW | Jun 25, 2002 | Substantially Equivalent |
| K013685 | PLLA CANNULATED INTERFERENCE SCREW | Jan 18, 2002 | Substantially Equivalent |
| K002040 | FMS SOLO | Sep 11, 2000 | Substantially Equivalent |
| K980808 | ENDO FMS UROLOGY | May 8, 1998 | Substantially Equivalent |
| K955500 | FMS ARTHOPROBE | Feb 5, 1996 | Substantially Equivalent |
| K954217 | ARTHROPLAST & ARTHRO-CUTTER | Oct 23, 1995 | Substantially Equivalent |
| K951843 | REF. 4102CV INTERMEDIARY TUBING, REF. 4509CV STERILE ZONE KIT | Jul 14, 1995 | Substantially Equivalent |
| K951702 | FMS HIGH FLOW ARTHRO-SHEATH | May 12, 1995 | Substantially Equivalent for Some Indications |
| K951701 | FMS ARTHRO-CUTTER | May 9, 1995 | Substantially Equivalent |