Gyrus ACMI

FDA UDI

Class II (US FDA UDI)

by Gyrus Acmi, Inc.

Identity

Trade Name: Gyrus ACMI FDA UDI
Generic Name: Electrosurgical system FDA UDI
Device Name: PC15 PLASMAKNIFE DISPOSABLE TIP FDA UDI
Model / Reference: 70353115 FDA UDI
Description: PC15 PLASMAKNIFE DISPOSABLE TIP FDA UDI

Identifiers

Primary DI / UDI-DI: 00821925040526 FDA UDI
510(k) Number: K041285 FDA UDI
FDA Product Code: GEI FDA UDI
GMDN Term: Electrosurgical system 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

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

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

K041285 also covers:

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 0ce42d76-98de-4275-afcb-f7c1a8dedf6b 34 fields · synced Jun 1, 2026