Identity
- Trade Name
- Exoflow™ FDA UDI
- Generic Name
- Surgical irrigation/aspiration tubing set FDA UDI
- Device Name
- Fluid management accessory disposable, outflow only FDA UDI
- Model / Reference
- R-10017 FDA UDI
- Description
- Fluid management accessory disposable, outflow only FDA UDI
Identifiers
- Catalog Number
- R-10017 FDA UDI
- Primary DI / UDI-DI
- 00859273007175 FDA UDI
- 510(k) Number
- K162770 FDA UDI
- FDA Product Code
- GEI FDA UDIHRX FDA UDI
- GMDN Term
- Surgical irrigation/aspiration tubing set FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.4400 FDA UDI888.1100 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
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
MR Unsafe FDA UDI
Category: Surgical irrigation/aspiration tubing set
Exoflow™ by RELIGN Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Surgical irrigation/aspiration tubing set.
- LAMIS Tubing — Mentor Texas LP · Class I
- Aspiration Tubing — BLACK & BLACK SURGICAL, INC. · Class II
- MB ULTRA-LIMP TUBING — The Wells Johnson Company · Class II
- INFILTRATION TUBING — BLACK & BLACK SURGICAL, INC. · Class II
- Autofuse Tubing — Mentor Texas LP · Class I
- Medline — MEDLINE INDUSTRIES, INC. · Class II
- ENDOFLOW II - PROBES - 4 holes diam.5 inch — Promepla · Class I
- Hysteroscopy set 2 spikes — Promepla · Class II
Cleared under the same submission
K162770 also covers:
- 3-in-1 SHAVER™ 4.2mm — RELIGN Corporation
- 3-in-1 SHAVER™ 5.0mm — RELIGN Corporation
- Curved Standard Shaver 3.4mm — RELIGN Corporation
- Dynablator™ — RELIGN Corporation
- Standard Burr 5.0mm — RELIGN Corporation
- Standard Shaver 3.4mm — RELIGN Corporation
- Tricera™ Controller — RELIGN Corporation
- Tricera™ Handpiece, Autoclavable — RELIGN Corporation
- Veriflow™ — RELIGN Corporation
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- RELIGN Corporation
Sources (1)
- FDA UDI 76d7bd8b-0e0f-4363-969c-4649aa016216 36 fields · synced Jun 9, 2026