Identity
- Trade Name
- EsoFLIP FDA UDI
- Generic Name
- Gastrointestinal/biliary dilation balloon catheter, non-medicated FDA UDI
- Device Name
- EsoFLIP Dilation Catheter for use with EndoFLIP System FDA UDI
- Model / Reference
- ES-330 FDA UDI
- Description
- EsoFLIP Dilation Catheter for use with EndoFLIP System FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05391530810043 FDA UDI
- 510(k) Number
- K132337 FDA UDI
- FDA Product Code
- PIE FDA UDIPID FDA UDI
- GMDN Term
- Gastrointestinal/biliary dilation balloon catheter, non-medicated FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 876.5980 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Dimensions & Sizes
- Size
- Outer Diameter — 30 Millimeter FDA UDI
Category: Gastrointestinal/biliary dilation balloon catheter, non-medicated
EsoFLIP by Covidien LP — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Gastrointestinal/biliary dilation balloon catheter, non-medicated.
- Disposable Dilation Balloon — Micro-Tech (Nanjing) Co., Ltd. · Class II
- Disposable Dilation Balloon — Micro-Tech (Nanjing) Co., Ltd. · Class II
- FUJIFILM — FUJIFILM Corporation · Class II
- Flex-Ez Stylet Wire Balloon Dilator — HOBBS MEDICAL, INC. · Class II
- Disposable Dilation Balloon — Micro-Tech (Nanjing) Co., Ltd. · Class II
- Disposable Dilation Balloon — Micro-Tech (Nanjing) Co., Ltd. · Class II
- Reliant(TM) Multistage Dilatation Balloon Catheter — Micro-Tech (Nanjing) Co., Ltd. · Class II
- MaxForce TTS — Boston Scientific · Class II
Cleared under the same submission
K132337 also covers:
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Covidien LP
Sources (1)
- FDA UDI 6f9e84bf-0dc1-4844-8dc9-7039110a7399 37 fields · synced May 30, 2026