FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SMITH & NEPHEW INTELIJET FLUID MANAGEMENT SYSTEMS
K Number: K050580
·
Decision Apr 20, 2005
Classifications
1
FEI Numbers
386
Registration Numbers
386
Same Product Code
680
Applicant Total
18
Review Days
44
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Basic Information
- Device Name
- SMITH & NEPHEW INTELIJET FLUID MANAGEMENT SYSTEMS
- K Number
- K050580
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.1100
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Smith & Nephew Endoscopy, Inc.
- Date Received
- March 7, 2005
- Decision Date
- April 20, 2005
- 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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| K093428 | SMITH & NEPHEW KNOTLESS INSTABILITY ANCHOR | Dec 17, 2009 | Substantially Equivalent |
| K083635 | SMITH & NEPHEW BIOSURE PK INTERFERENCE SCREW | Jan 30, 2009 | Substantially Equivalent |
| K083226 | SMITH & NEPHEW PEEK INTERFERENCE SCREW | Jan 30, 2009 | Substantially Equivalent |
| K082095 | ULTRASLIDE ACROMIOCLAVICULAR AND SYNDESMOTIC REPAIR DEVICE | Oct 21, 2008 | Substantially Equivalent |
| K992396 | BIORCI SCREW | Jan 12, 2000 | Substantially Equivalent |
| K991500 | SMITH & NEPHEW SUTURE LOK | Jul 14, 1999 | Substantially Equivalent |
| K972599 | ACUFEX SCREW CANNULA | Sep 19, 1997 | Substantially Equivalent |
| K971939 | SMITH & NEPHEW SUTURE COLLET | Aug 6, 1997 | Substantially Equivalent |