Identity
- Trade Name
- Olsen® EUDAMEDSymmetry Olsen FDA UDI
- Generic Name
- Open-surgery electrosurgical handpiece/electrode, bipolar, reusable FDA UDI
- Device Name
- Forceps, Bipolar (reusable) EUDAMED
- Model / Reference
- 10-1061 EUDAMEDFDA UDI
Identifiers
- Catalog Number
- 10-1061 FDA UDI
- Primary DI / UDI-DI
- 00841785100666 EUDAMEDFDA UDI
- Basic UDI-DI
- 08401132BipolarForcepRZV EUDAMED
- Direct Marketing DI
- 00841785100666 EUDAMED
- 510(k) Number
- K130669 FDA UDI
- FDA Product Code
- GEI FDA UDI
- EMDN Code
- L180401 OPEN ELECTROSURGERY FORCEPS, REUSABLE EUDAMED
- GMDN Term
- Open-surgery electrosurgical handpiece/electrode, bipolar, reusable FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 878.4400 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
No
Manufacturing Date
Yes
Category: Open-surgery electrosurgical handpiece/electrode, bipolar, reusable
Symmetry Olsen by Olsen Medical — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Open-surgery electrosurgical handpiece/electrode, bipolar, reusable.
- AESCULAP — AESCULAP, INC. · Class II
- Kirwan — KIRWAN SURGICAL PRODUCTS LLC · 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
- Kirwan — KIRWAN SURGICAL PRODUCTS LLC · Class II
- CODMAN® — Integra LifeSciences Production Corporation · Class II
Cleared under the same submission
K130669 also covers:
- Symmetry Olsen — Olsen Medical
- Symmetry Olsen — Olsen Medical
- Symmetry Olsen — Olsen Medical
- Symmetry Olsen — Olsen Medical
- Symmetry Olsen — Olsen Medical
- Symmetry Olsen — Olsen Medical
- Symmetry Olsen — Olsen Medical
- Symmetry Olsen — Olsen Medical
- Symmetry Olsen — Olsen Medical
- Symmetry Olsen — Olsen Medical
- Symmetry Olsen — Olsen Medical
- Symmetry Olsen — Olsen Medical
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| 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
- Olsen Medical
Sources (2)
- FDA UDI ee07de2d-a73d-40de-9bb6-bb2c00245535 34 fields · synced Oct 8, 2026
- EUDAMED a578479e-7a7d-4e84-acc4-6a1276119b88 61 fields · synced Oct 8, 2026