FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CODMAN LASER RODS
K Number: K853627
·
Decision Feb 7, 1986
Classifications
1
FEI Numbers
476
Registration Numbers
479
Same Product Code
2793
Applicant Total
145
Review Days
162
Basic Information
- Device Name
- CODMAN LASER RODS
- K Number
- K853627
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.4810
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- Codman & Shurtleff, Inc.
- Date Received
- August 29, 1985
- Decision Date
- February 7, 1986
- Product Code
- GEX
- Advisory Committee
- General, Plastic Surgery
- Review Advisory Committee
- SU
- 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 |
|---|---|---|---|
| GEX | Powered Laser Surgical Instrument | FDA class 2 | General, Plastic Surgery |
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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 |
| 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 |
| 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 |
| K162437 | Codman EDS3 CSF External Drainage System | Oct 28, 2016 | Substantially Equivalent |
| K140080 | ENVOY DISTAL ACCESS (DA) GUIDING CATHETER, 6F, 95CM & 105CM, STRAIGHT & XB, MPD & XB, MPC & XB | Apr 24, 2014 | Substantially Equivalent |
| K140307 | ENVOY GUIDING CATHETER | Apr 21, 2014 | Substantially Equivalent |
| K133625 | AGILITY 10 STANDARD & SOFT 0.01IN. X 195CM, AGILITY 14 STANDARD & SOFT 0.014IN X 205CM & XL 350CM, AGILITY 16 STANDARD & | Feb 24, 2014 | Substantially Equivalent |