Identity
- Trade Name
- Symmetry Olsen FDA UDI
- Generic Name
- Open-surgery electrosurgical handpiece/electrode, bipolar, single-use FDA UDI
- Model / Reference
- 20-5370K-28 FDA UDI
Identifiers
- Catalog Number
- 20-5370K-28 FDA UDI
- Primary DI / UDI-DI
- 00841785105951 FDA UDI
- 510(k) Number
- K130669 FDA UDI
- FDA Product Code
- GEI FDA UDI
- GMDN Term
- Open-surgery electrosurgical handpiece/electrode, bipolar, 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
No
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
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Radiation Sterilization FDA UDI
Category: Open-surgery electrosurgical handpiece/electrode, bipolar, single-use
Symmetry Olsen by Olsen Medical — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Open-surgery electrosurgical handpiece/electrode, bipolar, single-use.
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- Kirwan — KIRWAN SURGICAL PRODUCTS LLC · Class II
- Bausch & Lomb — Bausch & Lomb Incorporated · Class II
- Kirwan — KIRWAN SURGICAL PRODUCTS LLC · Class II
- AESCULAP — AESCULAP, INC. · 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 (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
- Olsen Medical
Sources (1)
- FDA UDI f68f062c-3bad-4654-8830-feef1892f29c 34 fields · synced May 31, 2026