Esophageal Sheath With Distal Balloon Anchor
The Esophageal Sheath With Distal Balloon Anchor is a device used to provide an endoluminal pathway to facilitate insertion of an endoscope or other validated device into the upper gastrointestinal tract, with a distal balloon anchor to assist in keeping the sheath in place and facilitate proper positioning. It is classified as FDA Class 2, requiring 510(k) premarket notification under regulation 876.1510 in the Gastroenterology and Urology specialty. The product code is QGG. It is not an implant and is not life-sustaining.
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Basic Information
- Product Code
- QGG
- Device Class
- FDA class 2
- Regulation Number
- 876.1510
- Medical Specialty
- Gastroenterology, Urology
- Review Panel
- GU
- Submission Type
- 1
Device Characteristics
Definition
Used to provide an endoluminal pathway to facilitate insertion of an endoscope or other specifically validated device into the upper gastrointestinal tract. A distal balloon anchor assists in keeping the sheath in place to facilitate positioning of the endoscope or other specifically validated device.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 1 510(k) clearance via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K191078 | BAROnova Access Sheath Kit | Jul 22, 2019 | Unknown | Baronova, Inc. |