Injection Gold Probe
510(k) K961349
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK961349 | Date15 May 1996 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
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- Withdrawn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, 19 Sep 2026
The Injection Gold Probe Catheter is an electrosurgical, endoscopic catheter designed for bipolar electrohemostasis. It delivers controlled coagulation to achieve uniform tissue burn and effective hemostasis, particularly in challenging anatomical positions during endoscopic procedures. This device is classified as a Class II medical device under FDA regulations and is intended for use in gastroenterology and urology specialties.
The catheter is supplied as a single-use, non-sterile device, requiring sterilisation prior to use. It is available in a 7F (2.3mm) diameter with a length of 210cm, featuring a standard electrical connector for bipolar electrohemostasis. Compliance with FDA 510(k) clearance (K961349) and regulatory standards (876.4300) ensures its suitability for controlled clinical use in endoscopic settings. Storage and handling must adhere to manufacturer guidelines to maintain device integrity.
Other devices from Boston Scientific
Questions
AI-generated answers, 19 Sep 2026
What specialties is the Injection Gold Probe Catheter intended for, and how does it help in those fields?
The Injection Gold Probe Catheter is designed for use in gastroenterology and urology specialties. It delivers controlled bipolar electrohemostasis, which helps achieve uniform tissue coagulation and effective hemostasis—particularly useful in challenging anatomical positions during endoscopic procedures. This makes it ideal for managing bleeding or sealing tissue in minimally invasive surgeries.
Is the Injection Gold Probe Catheter single-use or reusable, and what does that mean for my workflow?
The Injection Gold Probe Catheter is single-use and non-sterile, meaning it must be sterilized before use according to manufacturer guidelines. This ensures patient safety but requires proper sterilization protocols (e.g., autoclave or chemical sterilization) before each procedure, which may impact workflow planning and inventory management.
What size and length options are available for the Injection Gold Probe Catheter, and how might that affect my procedure?
The catheter is available in a single size: 7F (2.3mm) diameter with a 210cm length. This design is optimized for endoscopic procedures, allowing for flexibility and reach in tight anatomical spaces. The length and diameter are standardized, so compatibility with existing endoscopic tools should be verified before use.
How should I store the Injection Gold Probe Catheter to maintain its integrity and performance?
The device must be stored following manufacturer guidelines to preserve its integrity. Since it is non-sterile and single-use, it should be kept in a clean, dry environment away from direct sunlight or extreme temperatures. Proper storage ensures the catheter remains functional and ready for sterilization when needed, avoiding degradation or damage.
What regulatory pathway does the Injection Gold Probe Catheter follow, and how does that affect its use in clinical settings?
The Injection Gold Probe Catheter follows the FDA 510(k) clearance pathway, specifically K961349, and is classified as a Class II medical device under FDA regulations. This means it has been determined to be substantially equivalent to a legally marketed predicate device, ensuring its safety and effectiveness for controlled clinical use in endoscopic hemostasis procedures. Compliance with FDA standards (e.g., 876.4300) is maintained.