Identity
- Trade Name
- Kirwan FDA UDI
- Generic Name
- Open-surgery electrosurgical handpiece/electrode, bipolar, reusable FDA UDI
- Device Name
- 9 3/4" Reusable Bipolar Forceps, Tines Reduced 20%, Parallel Tines Identical to MIS Style, Ball/Socket Soft Stop, 0.7mm Tips, Angled Up 90 Deg. for 3mm, 2mm in Contact When Closed, Cup Marked "TS3-L" (Special) FDA UDI
- Model / Reference
- 12-1130AUS FDA UDI
- Description
- 9 3/4" Reusable Bipolar Forceps, Tines Reduced 20%, Parallel Tines Identical to MIS Style, Ball/Socket Soft Stop, 0.7mm Tips, Angled Up 90 Deg. for 3mm, 2mm in Contact When Closed, Cup Marked "TS3-L" (Special) FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00841019118276 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 — 9.75 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
Similar devices
Also classified as Open-surgery electrosurgical handpiece/electrode, bipolar, reusable.
- AESCULAP — AESCULAP, INC. · Class II
- ASSI — ACCURATE SURGICAL & SCIENTIFIC INSTRUMENTS CORP. · Class II
- Ambler Surgical — Ambler Surgical, LLC · Class II
- STINGRAY SURGICAL PRODUCTS — STINGRAY SURGICAL PRODUCTS L.L.C. · Class II
- STINGRAY SURGICAL PRODUCTS — STINGRAY SURGICAL PRODUCTS L.L.C. · Class II
- CODMAN® — Integra LifeSciences Production Corporation · Class II
- STINGRAY SURGICAL PRODUCTS — STINGRAY SURGICAL PRODUCTS L.L.C. · Class II
- Guenter Bissinger Medizintechnik GmbH — Günter Bissinger Medizintechnik GmbH · Class II
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Kirwan Surgical Products Llc
Sources (1)
- FDA UDI 2c326c90-545a-4e06-a7a3-afc2f6b6b5cd 36 fields · synced May 29, 2026