Identity
- Trade Name
- PowerPumpTM dp System Interface Cable, Type 5 FDA UDI
- Generic Name
- Electrical-only medical device connection cable, reusable FDA UDI
- Device Name
- Compatible with: Arthrex APS FDA UDI
- Model / Reference
- 941033G FDA UDI
- Description
- Compatible with: Arthrex APS FDA UDI
Identifiers
- Primary DI / UDI-DI
- 17350021986778 FDA UDI
- 510(k) Number
- K093409 FDA UDI
- FDA Product Code
- HRX FDA UDI
- GMDN Term
- Electrical-only medical device connection cable, reusable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.1100 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Electrical-only medical device connection cable, reusable
PowerPumpTM dp System Interface Cable, Type 5 by Insightra Medical, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Electrical-only medical device connection cable, reusable.
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- Symmetry Olsen — Olsen Medical · Class II
- Connection Cable — Shenzhen Keborui Electronics Co., Ltd · Class I
- TC-HEART LUNG DIN INTFC CA STOCKET — ARGON CRITICAL CARE SYSTEMS SINGAPORE PTE. LTD. · Class II
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- ECG Cable — Edan Instruments,Inc. · Class I
Cleared under the same submission
K093409 also covers:
- Double Pump Day cassette/ Double Pump RF Day cassette — INSIGHTRA MEDICAL, INC.
- Double Pump Patient cassette — INSIGHTRA MEDICAL, INC.
- Double Pump RF — INSIGHTRA MEDICAL, INC.
- Double Pump RF Patient cassette — INSIGHTRA MEDICAL, INC.
- Double Pump Single/ Double Pump RF Single — INSIGHTRA MEDICAL, INC.
- Foot Control 2-pedal — INSIGHTRA MEDICAL, INC.
- Foot Control 4-pedal — INSIGHTRA MEDICAL, INC.
- PowerPumpTM dp System — INSIGHTRA MEDICAL, INC.
- PowerPumpTM dp System Day Cassette — INSIGHTRA MEDICAL, INC.
- PowerPumpTM dp System Foot Control — INSIGHTRA MEDICAL, INC.
- PowerPumpTM dp System Interface Cable, Type 1 — INSIGHTRA MEDICAL, INC.
- PowerPumpTM dp System Interface Cable, Type 3 — INSIGHTRA MEDICAL, INC.
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
- Insightra Medical, Inc.
Sources (1)
- FDA UDI a0b5208a-dccf-4e56-a18c-d066b4e14961 34 fields · synced Jun 8, 2026