Identity
- Trade Name
- Bovie FDA UDI
- Generic Name
- Open-surgery electrosurgical electrode, monopolar, single-use FDA UDI
- Device Name
- Electrode Sharp Tip 100/Bx FDA UDI
- Model / Reference
- A804 FDA UDI
- Description
- Electrode Sharp Tip 100/Bx FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00887482177051 FDA UDI
- 510(k) Number
- K931338 FDA UDI
- FDA Product Code
- HGI FDA UDI
- GMDN Term
- Open-surgery electrosurgical electrode, monopolar, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 884.4120 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
Category: Open-surgery electrosurgical electrode, monopolar, single-use
Bovie by Symmetry Surgical Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Open-surgery electrosurgical electrode, monopolar, single-use.
- Kirwan — KIRWAN SURGICAL PRODUCTS LLC · Class II
- Symmetry Olsen — Olsen Medical · Class II
- FlexTrode® Malleable Electrode — ELLIQUENCE LLC · Class II
- 33cm Laparoscopic L-Wire Split; Blue PTFE; Black Insulation; PL — XODUS MEDICAL, INC. · Class II
- star Bipolar RF Electrode — STARMED CO., LTD · Class IIb
- 4" Blade Tip Ext Ins; Stainless Steel; Blue Ins; Black Ext Ins — XODUS MEDICAL, INC. · Class II
- VIVA RF electrode — STARMED CO., LTD · Class IIb
- CONMED — Conmed Corporation · Class II
Cleared under the same submission
K931338 also covers:
- MEDLINE — MEDLINE INDUSTRIES, INC.
- MEDLINE — MEDLINE INDUSTRIES, INC.
- MEDLINE — MEDLINE INDUSTRIES, INC.
- MEDLINE — MEDLINE INDUSTRIES, INC.
- MEDLINE — MEDLINE INDUSTRIES, INC.
- MEDLINE — MEDLINE INDUSTRIES, INC.
- MEDLINE — MEDLINE INDUSTRIES, INC.
- MEDLINE — MEDLINE INDUSTRIES, INC.
- MEDLINE — MEDLINE INDUSTRIES, INC.
- Bovie — SYMMETRY SURGICAL INC.
- Bovie — SYMMETRY SURGICAL INC.
- Bovie — SYMMETRY SURGICAL INC.
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
- Symmetry Surgical Inc.
Sources (1)
- FDA UDI 223d4753-190f-4701-9f7e-f6c40df7dc10 35 fields · synced Jun 8, 2026