FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CODMAN SOF'WIRE (TM) KIT
K Number: K915581
·
Decision Jan 16, 1992
Classifications
1
FEI Numbers
155
Registration Numbers
155
Same Product Code
128
Applicant Total
152
Review Days
34
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
- CODMAN SOF'WIRE (TM) KIT
- K Number
- K915581
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3010
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Codman & Shurtleff, Inc.
- Date Received
- December 13, 1991
- Decision Date
- January 16, 1992
- Product Code
- JDQ
- 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 |
|---|---|---|---|
| JDQ | Cerclage, Fixation | FDA class 2 | Orthopedic |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (JDQ), ordered by most recent decision date.
Stitch Cerclage Suture Tapes
FDA 510(k)
FDA Class 2
·Orthopedic
Arthrex FiberTape and TigerTape Cerclage Sutures; Arthrex Radiopaque FiberTape Cerclage Sutures
FDA 510(k)
FDA Class 2
·Orthopedic
Mbrace Cable
FDA 510(k)
FDA Class 2
·Orthopedic
ACCORD Cable System
FDA 510(k)
FDA Class 2
·Orthopedic
VariTrax Sternal CircumFixation System
FDA 510(k)
FDA Class 2
·Orthopedic
Arthrex Radiopaque FiberTape Cerclage sutures
FDA 510(k)
FDA Class 2
·Orthopedic
Other Clearances by Codman & Shurtleff, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K193380 | CERENOVUS Large Bore Catheter; CERENOVUS Aspiration Tubing Set | Jul 20, 2020 | Substantially Equivalent |
| K191237 | CERENOVUS Large Bore Catheter | Nov 8, 2019 | Substantially Equivalent |
| K173192 | CereLink ICP Sensor Basic Kit, CereLink ICP Sensor Metal Skull Bolt Kit, CereLink ICP Sensor Plastic Skull Bolt Kit, CereLink ICP Sensor Ventricular Catheter Kit | Nov 8, 2017 | Substantially Equivalent |
| K172537 | Codman EDS 3 CSF External Drainage System, Codman EDS 3 CSF External Drainage System Collection Bag | Oct 16, 2017 | Substantially Equivalent |
| K172022 | CODMAN Hydrocephalus Valves, Catheters & Accessories (Bundled) | Oct 3, 2017 | Substantially Equivalent |
| K171862 | GALAXY G3 Mini Microcoil Delivery System | Sep 25, 2017 | Substantially Equivalent |
| K171747 | MICRUSFRAME 10 Stretch Resistant Microcoil Delivery System, MICRUSFRAME 18 Stretch Resistant Microcoil Delivery System, DELTAFILL 18 Stretch Resistant Microcoil Delivery System, DELTAXSFT 10 Stretch Resistant Microcoil Delivery System, GALAXY G3 FILL and GALAXY G3 XSFT Stretch Resistant Microcoil Delivery System | Jul 14, 2017 | Substantially Equivalent |
| K171653 | YOGA Microcatheter, 0.032, 150cm, Back Up and Extra Back Up | Jul 3, 2017 | Substantially Equivalent |
| K162563 | YOGA Microcatheter | Jan 5, 2017 | Substantially Equivalent |
| K162437 | Codman EDS3 CSF External Drainage System | Oct 28, 2016 | Substantially Equivalent |