FDA.reportPublic FDA data

Gyrus ACMI

Primary DI
00821925004283
Brand
Gyrus ACMI
Company
Gyrus ACMI, LLC
Model
257F6
Device description
Fulgurating Electrode, Ball Tip 6 Fr, (2 mm) 37 cm, Color Coded Green
Published
2024-07-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
FASElectrode, Electrosurgical, Active, Urological

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FASElectrode, Electrosurgical, Active, UrologicalGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K890328000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K890328000ADULT RESECTOSCOPECircon Video1990-02-06HIH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00821925004283PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00821925004283008219250042838219250042830821925004283

GMDN Terms#

Term, Definition table
TermDefinition
Endoscopic electrosurgical electrode, monopolar, reusableAn invasive, distal component of an electrosurgical assembly intended to deliver electrosurgical current in a monopolar configuration (i.e., used with a patient contact return electrode) to tissues for cutting/coagulation/ablation during endoscopic (e.g., laparoscopic, arthroscopic) surgery. It available in a variety of forms (e.g., exchangeable electrode for electrosurgical forceps, rigid electrode, flexible endoscopic probe) which may include a lumen for suction/irrigation. It does not include a handpiece/housing and has no electrical or mechanical controls (e.g., does not include controlling ring-handles); it is not intended for gas-enhanced electrosurgery. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
007198742
Device count
1
DM exempt
true
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00821925033900DIEGO701390022024-07-25
00821925033917DIEGO701390062024-07-24
00821925034419DIEGO701390332024-07-23
00821925034730Gyrus ACMI703531002017-05-11
00821925034754Gyrus ACMI703531122017-05-11
00821925035935OLYMPUS37402016-10-03
00821925001428GYRUS ACMICW-USLPC2016-10-13
00821925035874OLYMPUS30002016-09-30
00821925035911Gyrus ACMI34002016-10-12
00821925041547Gyrus ACMI30252016-09-30
00821925010567Gyrus ACMI39992024-07-24
00821925002746Gyrus ACMIENDO-ST2016-10-14
00821925011410DIEGO703390012016-10-12
00821925011441DIEGO703380002017-05-11
00821925021594SMART701421682015-10-24
00821925021617VOCOM701430192015-10-24
00821925026179Diego703380122016-10-06
00821925028746Diego703390002016-10-06
00821925034174Gyrus ACMI701410322015-10-24
00821925035898OLYMPUS30062016-09-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
03665415002710Bipolar electrode UNIV / THIN, extra length (round ; Fr26)LAMIDEY NOURY MEDICALFAS2026-07-10
08904148106339ACEACE MEDICAL DEVICES PRIVATE LIMITEDFAS2025-05-03
08904148106353ACEACE MEDICAL DEVICES PRIVATE LIMITEDFAS2025-05-03
08904148101402ACEACE MEDICAL DEVICES PRIVATE LIMITEDFAS2025-04-28
08904148101525ACEACE MEDICAL DEVICES PRIVATE LIMITEDFAS2025-04-28
08904148101570ACEACE MEDICAL DEVICES PRIVATE LIMITEDFAS2025-04-28
08904148101587ACEACE MEDICAL DEVICES PRIVATE LIMITEDFAS2025-04-28
08904148101600ACEACE MEDICAL DEVICES PRIVATE LIMITEDFAS2025-04-28
08904148101617ACEACE MEDICAL DEVICES PRIVATE LIMITEDFAS2025-04-28
08904148101624ACEACE MEDICAL DEVICES PRIVATE LIMITEDFAS2025-04-28
08904148101822ACEACE MEDICAL DEVICES PRIVATE LIMITEDFAS2025-04-28
08904148101839ACEACE MEDICAL DEVICES PRIVATE LIMITEDFAS2025-04-28
08904148101846ACEACE MEDICAL DEVICES PRIVATE LIMITEDFAS2025-04-28
08904148101853ACEACE MEDICAL DEVICES PRIVATE LIMITEDFAS2025-04-28
08904148101860ACEACE MEDICAL DEVICES PRIVATE LIMITEDFAS2025-04-28
08904148101877ACEACE MEDICAL DEVICES PRIVATE LIMITEDFAS2025-04-28
08904148101891ACEACE MEDICAL DEVICES PRIVATE LIMITEDFAS2025-04-28
08904148102157ACEACE MEDICAL DEVICES PRIVATE LIMITEDFAS2025-04-28
08904148102164ACEACE MEDICAL DEVICES PRIVATE LIMITEDFAS2025-04-28
08904148102379ACEACE MEDICAL DEVICES PRIVATE LIMITEDFAS2025-04-28
08904148103628ACEACE MEDICAL DEVICES PRIVATE LIMITEDFAS2025-04-28
08904148105868ACEACE MEDICAL DEVICES PRIVATE LIMITEDFAS2025-04-28
08904148105875ACEACE MEDICAL DEVICES PRIVATE LIMITEDFAS2025-04-28
08904148105882ACEACE MEDICAL DEVICES PRIVATE LIMITEDFAS2025-04-28
08904148106322ACEACE MEDICAL DEVICES PRIVATE LIMITEDFAS2025-04-28
08904148106346ACEACE MEDICAL DEVICES PRIVATE LIMITEDFAS2025-04-28
03665415002253Bipolar electrode / VAPORIZATION (SIDE load; round fitting ; Fr26)LAMIDEY NOURY MEDICALFAS2023-04-21
03665415002277Bipolar cutting loop / THICK (SIDE load; round fitting ; Fr26)LAMIDEY NOURY MEDICALFAS2023-04-21
03665415002291Bipolar cutting loop / THIN (SIDE load; round fitting ; Fr26)LAMIDEY NOURY MEDICALFAS2023-04-21
03665415002413Bipolar electrode / NEEDLE (SIDE LOAD.round fitting ; Fr26)LAMIDEY NOURY MEDICALFAS2023-04-21