Identity
- Trade Name
- StrykeFlow FDA UDI
- Generic Name
- Surgical irrigation/aspiration tubing set FDA UDI
- Device Name
- Pressure System Disposable Suction/Irrigator, Single Spike Tubing FDA UDI
- Model / Reference
- 0250070530 FDA UDI
- Description
- Pressure System Disposable Suction/Irrigator, Single Spike Tubing FDA UDI
Identifiers
- Catalog Number
- 250-070-530 FDA UDI
- Primary DI / UDI-DI
- 07613327061352 FDA UDI
- 510(k) Number
- K963646 FDA UDI
- FDA Product Code
- GEI FDA UDI
- GMDN Term
- Surgical irrigation/aspiration tubing set FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.4400 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
Category: Surgical irrigation/aspiration tubing set
StrykeFlow by Stryker Corp. — 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
K963646 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Stryker Corp.
Sources (1)
- FDA UDI c99d7c5b-8c24-4e2b-acc6-ddb99c8e6220 36 fields · synced Jun 8, 2026