Identity
- Trade Name
- Kirwan FDA UDI
- Generic Name
- Open-surgery electrosurgical handpiece/electrode, bipolar, reusable FDA UDI
- Device Name
- Non-Stick Bipolar Coagulation Forceps 7 7/8" (20cm) Yasargil Bayonet, 0.5mm Tip FDA UDI
- Model / Reference
- 20-1118AU FDA UDI
- Description
- Non-Stick Bipolar Coagulation Forceps 7 7/8" (20cm) Yasargil Bayonet, 0.5mm Tip FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00841019104781 FDA UDI
- 510(k) Number
- K811820 FDA UDI
- FDA Product Code
- GEI FDA UDI
- GMDN Term
- Open-surgery electrosurgical handpiece/electrode, bipolar, reusable 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
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Dimensions & Sizes
- Size
- Length — 7.88 Inch FDA UDI
Category: Open-surgery electrosurgical handpiece/electrode, bipolar, reusable
Kirwan by Kirwan Surgical Products Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Open-surgery electrosurgical handpiece/electrode, bipolar, reusable.
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Cleared under the same submission
K811820 also covers:
- ASSI — ACCURATE SURGICAL & SCIENTIFIC INSTRUMENTS CORP.
- ASSI — ACCURATE SURGICAL & SCIENTIFIC INSTRUMENTS CORP.
- ASSI — ACCURATE SURGICAL & SCIENTIFIC INSTRUMENTS CORP.
- ASSI — ACCURATE SURGICAL & SCIENTIFIC INSTRUMENTS CORP.
- ASSI — ACCURATE SURGICAL & SCIENTIFIC INSTRUMENTS CORP.
- ASSI — ACCURATE SURGICAL & SCIENTIFIC INSTRUMENTS CORP.
- ASSI — ACCURATE SURGICAL & SCIENTIFIC INSTRUMENTS CORP.
- Axon — Axon Medical
- Axon — Axon Medical
- 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 fdca2abe-45e4-4bd7-a28e-125162821401 36 fields · synced May 30, 2026