Manufacturer
Point Robotics MedTech, Inc.“POINT” Kinguide Robotic-Assisted Surgical System
Country / Region:Taiwan (TW)Submission type:Traditional
Product code OLO· 21 CFR 882.4560
Product code
OLO
21 CFR 882.4560
Predicate devices
0
Cited in this 510(k)
Device details
FDA 510(k) registration fields
- K number
- K220241
- Device name
- “POINT” Kinguide Robotic-Assisted Surgical System
- Company
- Point Robotics MedTech, Inc.
- Country / Region
- Taiwan(TW)
- Product code
- OLO
- Device class
- Class 2
- Regulation number
- 21 CFR 882.4560
- Date received
- 2022-01-28
- Decision date
- 2022-08-09
- Submission type
- Traditional
Predicate devices
0No predicate K numbers were extracted
The Summary PDF may not be parsed yet, or this submission may not cite predicate devices
Cited as predicate
1“POINT” Kinguide Agile Hybrid Navigation System
1 submission cite K220241 as a predicate