Microvasive Gold Probe
by Boston Scientific 2 variants
510(k) K885005
Active
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK885005 | Date1 Feb 1989 | StatusActive |
Official records
- FDA 510(k) database K885005
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- KNS
- FDA applicant
- Boston Scientific Corp
- Device class
- Class II
- Regulation
- 21 CFR Part 876.4300
- Advisory committee
- Gastroenterology, Urology
- FDA decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The Microvasive Gold Probe is an electrosurgical, endoscopic catheter designed for bipolar coagulation and hemostasis. It delivers controlled thermal energy to achieve uniform tissue ablation and sealing, particularly in challenging anatomical positions during endoscopic procedures. The device is classified under Unit, Electrosurgical, Endoscopic (With or Without Accessories) and is intended for use in gastroenterology and urology specialties.
This device is supplied as a single-use, non-sterile catheter and requires sterile preparation prior to use. It is intended for in-office or procedural room settings and is compatible with standard endoscopic equipment. The Microvasive Gold Probe has received FDA 510(k) clearance (K885005) under the Substantially Equivalent determination, adhering to regulatory standards for Class II devices. No MRI safety information or reusable variants are specified in the data.