← Back to catalogue
Lungpoint Tools (lungpoint Sheath, Lungpoint Dilation Balloon)
FDA 510(k)Class II (US FDA 510(k))
510(k) K131234
Identifiers
- 510(k) Number
- K131234 FDA 510(k)
- FDA Product Code
- EOQ FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 874.4680 FDA 510(k)
- Regulation Number
- 874.4680 FDA 510(k)
- Advisory Committee
- Ear, Nose, Throat FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
Lungpoint Tools (lungpoint Sheath, Lungpoint Dilation Balloon) by Broncus Medical Inc. — Class II — FDA_510K — listed in FDA 510(k)
Authorization Coverage (1 country)
Regulatory Authorizations
United States Active
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K131234 | Class II | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Broncus Medical Inc.
- FDA Applicant
- Broncus Medical, Inc.
Sources (1)
- FDA 510(k) K131234 24 fields · synced Jun 19, 2026