Identity
- Trade Name
- Gyrus ACMI FDA UDI
- Generic Name
- Electrosurgical system FDA UDI
- Device Name
- DISPOSABLE BIPOLAR NASAL CAUTERY - SINGLE USE 18 GAUGE TIP, LG OF TIP 4.0 MM OVERALL LG 175 MM FDA UDI
- Model / Reference
- 131500 FDA UDI
- Description
- DISPOSABLE BIPOLAR NASAL CAUTERY - SINGLE USE 18 GAUGE TIP, LG OF TIP 4.0 MM OVERALL LG 175 MM FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00821925034433 FDA UDI
- 510(k) Number
- K864402 FDA UDI
- FDA Product Code
- HQO FDA UDI
- GMDN Term
- Electrosurgical system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 886.4115 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Electrosurgical system
Gyrus ACMI by Gyrus Acmi, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Electrosurgical system.
- Bovie — BOVIE MEDICAL CORPORATION · Class II
- Macan — Macan Manufacturing · Class II
- Macan — Macan Manufacturing · Class II
- T4 Fine wire electrode — BONART CO., LTD. · Class II
- Macan — Macan Manufacturing · Class II
- DeRoyal — DEROYAL INDUSTRIES, INC. · Class II
- Bovie — BOVIE MEDICAL CORPORATION · Class II
- BOVIE — BOVIE MEDICAL CORPORATION · Class II
Cleared under the same submission
K864402 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.
- Alpin — Alpin Surgical Specialties Inc
- Alpin — Alpin Surgical Specialties Inc
- Ambler Surgical — Ambler Surgical, LLC
- Ambler Surgical — Ambler Surgical, LLC
- Ambler Surgical — Ambler Surgical, LLC
- Ambler Surgical — Ambler Surgical, 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
- Gyrus Acmi, Inc.
Sources (1)
- FDA UDI 6e34819f-48e4-41a0-9a43-d741f12f717e 34 fields · synced Jun 8, 2026