Resolution Clip
by Boston Scientific 2 variants
510(k) K142973
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK142973 | Date1 Dec 2014 | 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- Withdrawn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
- PKL
- FDA applicant
- Boston Scientific Corporation
- Device class
- Class II
- Regulation
- 21 CFR Part 876.4400
- Advisory committee
- Gastroenterology, Urology
- FDA decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 19 Sep 2026
The Resolution Clip is a Hemostatic Metal Clip for the GI Tract, designed to achieve hemostasis, facilitate endoscopic marking, and secure jejunal feeding tubes. Its radiopaque construction enables visibility under fluoroscopy, ensuring precise placement during procedures.
This device is supplied as a single-use, reusable clip system intended for use in gastroenterology and urology settings. It is classified as a Class II medical device under FDA regulation 876.4400 and holds an FDA 510(k) clearance (K142973). Available in multiple configurations, including the Resolution 360 Clip (235 cm) and Resolution 360 ULTRA (17 mm jaw opening), it is engineered for controlled clip placement and procedural accuracy.
Other devices from Boston Scientific
Questions
AI-generated answers, 19 Sep 2026
What are the primary clinical uses of the Resolution Clip in endoscopic procedures?
The Resolution Clip is designed to achieve hemostasis (stopping bleeding) in the gastrointestinal (GI) tract, help mark areas during endoscopy for future reference, and securely fasten jejunal feeding tubes. Its radiopaque material also allows for clear visualization under fluoroscopy, ensuring accurate placement during procedures.
Is the Resolution Clip intended for single-use or reusable applications, and how does this affect its clinical workflow?
The Resolution Clip is supplied as a single-use, reusable clip system, meaning the clip itself is reusable, but the delivery components are intended for single-use. This design balances cost efficiency with procedural safety, as reusable clips reduce waste while maintaining sterility protocols for each use.
What sizes or configurations are available for the Resolution Clip, and how might this impact procedure selection?
The Resolution Clip comes in multiple configurations, including the Resolution 360 Clip (235 cm length) and the Resolution 360 ULTRA (17 mm jaw opening). The jaw opening size is particularly relevant for procedures requiring wider tissue capture, while the length accommodates varying endoscopic access needs, ensuring flexibility for both gastroenterology and urology applications.
How should the Resolution Clip be stored to maintain its integrity and functionality?
While the data does not specify exact storage conditions, as a reusable medical device, the Resolution Clip should be stored in a clean, dry environment away from direct sunlight or extreme temperatures. Proper packaging and adherence to manufacturer guidelines (e.g., sterilization protocols if applicable) are critical to preserve its structural integrity and radiopacity for accurate fluoroscopic visualization.
What regulatory pathway was followed for the Resolution Clip’s FDA clearance, and what does this imply for its safety and performance?
The Resolution Clip received FDA 510(k) clearance (K142973) under the Traditional pathway, with a determination of Substantially Equivalent (SESE) to a predicate device. This means the FDA reviewed it against an existing, legally marketed device and concluded it has the same intended use, technological characteristics, and performance as the predicate, ensuring its safety and effectiveness for hemostasis, marking, and tube securing in the GI tract.