Identity
- Trade Name
- Kirwan FDA UDI
- Generic Name
- Electrical-only medical device connection cable, single-use FDA UDI
- Device Name
- Disposable Irrigation Bipolar Cord FDA UDI
- Model / Reference
- 10-4601 FDA UDI
- Description
- Disposable Irrigation Bipolar Cord FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00841019101810 FDA UDI
- 510(k) Number
- K831236 FDA UDI
- FDA Product Code
- GEI FDA UDI
- GMDN Term
- Electrical-only medical device connection cable, single-use 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
Radiation Sterilization FDA UDI
Category: Electrical-only medical device connection cable, single-use
Kirwan by Kirwan Surgical Products Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- Sterile electrode's cable — Alpha Omega Engineering Corp. · Class II
Cleared under the same submission
K831236 also covers:
- Advanced Med-Surg Concepts — Advanced Med-Surg Concepts, Inc
- CONMED — Conmed Corporation
- GYRUS ACMI, INC — Gyrus Acmi, Inc.
- Integra® Jarit® — Integra LifeSciences Production Corporation
- Integra® Jarit® — Integra LifeSciences Production Corporation
- Integra® Jarit® — Integra LifeSciences Production Corporation
- Miltex® Padgett® — Integra LifeSciences Production Corporation
- Kirwan — KIRWAN SURGICAL PRODUCTS LLC
- Kirwan — KIRWAN SURGICAL PRODUCTS LLC
- Kirwan — KIRWAN SURGICAL PRODUCTS LLC
- Kirwan — KIRWAN SURGICAL PRODUCTS LLC
- Kirwan — KIRWAN SURGICAL PRODUCTS LLC
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
- Kirwan Surgical Products Llc
Sources (1)
- FDA UDI 1a5b9a42-32d6-4c02-8438-863ba07054e5 35 fields · synced May 29, 2026