Gold Probe Bipolar Electrohemostasis Catheter; Injection Gold Probe Bipolar Electrohemostasis Catheter
FDA 510(k) clearance K232633 · decided 2023-11-28
Clearance details
- K-number
- K232633
- Device name
- Gold Probe Bipolar Electrohemostasis Catheter; Injection Gold Probe Bipolar Electrohemostasis Catheter
- Applicant
- Boston Scientific
- Decision
- Substantially Equivalent
- Date received
- 2023-08-30
- Decision date
- 2023-11-28
- Days to decision
- 90 days
- Clearance type
- Traditional
- Product code
- KNS
- Device class
- 2
- Regulation number
- 876.4300
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Marlboro, MA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
Recalls involving this device
No recalls on record reference this clearance.