FDA.reportPublic FDA data

PK BUTTON (BOX OF 5)

Primary DI
00821925011519
Brand
PK BUTTON (BOX OF 5)
Company
Gyrus Acmi, Inc.
Model
786500
Published
2016-10-04
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
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
K093181000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K093181000GYRUS ACMI PK BUTTON ELECTRODEGyrus Acmi, Inc.2010-02-24FAS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00821925011519PackageGS15In Commercial Distribution
00821925039520PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00821925011519008219250115198219250115190821925011519
00821925039520008219250395208219250395200821925039520

GMDN Terms#

Term, Definition table
TermDefinition
Endoscopic electrosurgical handpiece/electrode, bipolar, single-useA sterile electrosurgical device which consists of a handpiece with mechanical and/or electrical controls, and a bipolar electrode intended to deliver electrosurgical current from a system generator directly to tissues for cutting/coagulation/ablation during endoscopic (including laparoscopic, arthroscopic) surgery, and may in addition be intended for open surgery; it is not intended for focal percutaneous ablation. It includes a long thin electrode connected to the handpiece, and may include a lumen for suction/irrigation; it is available in a variety of forms (e.g., forceps, rigid probe with controls). This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
007198742
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00821925043916SOLTIVETFL-FBX150BS2024-08-01
00821925043930SOLTIVETFL-FBX200S2024-08-01
00821925043978SOLTIVETFL-FBX200BS2024-08-01
00821925043992SOLTIVETFL-FBX365S2024-08-01
00821925044074SOLTIVETFL-FBX940S2024-08-01
00821925000933Gyrus ACMI207142024-07-25
00821925025929DIEGO701390002024-07-25
00821925025936DIEGO701390022024-07-25
00821925025974DIEGO701390102024-07-25
00821925025967DIEGO701390082024-07-25
00821925000469Gyrus ACMI005-5-1012024-07-25
00821925000476Gyrus ACMI005-5-2012024-07-25
00821925000483Gyrus ACMI005-5-3012024-07-25
00821925000490Gyrus ACMI005-5-4012024-07-25
00821925010932Gyrus ACMI608BX2024-07-25
00821925025943DIEGO701390042024-07-25
00821925022379Gyrus ACMI8909122024-07-25
00821925010819Gyrus ACMI7035-30062024-07-25
00821925043077DIEGO ELITEBB4000SC2024-07-25
00821925043879SOLTIVETFL-FBX150S2024-07-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
10801334000707Greenwald Surgical Company, Inc.GRACE MANUFACTURING, INC.FAS2017-05-03
08714729875604Signature Series PROSURG INCFAS2016-09-30
07613327055313NASTRYKER CORPORATIONFAS2016-09-23
07613327055399NASTRYKER CORPORATIONFAS2016-09-23
07613327055405NASTRYKER CORPORATIONFAS2016-09-23