FDA.reportPublic FDA data

Gyrus ACMI

Primary DI
00821925038547
Brand
Gyrus ACMI
Company
Gyrus ACMI, LLC
Model
PKWE-AD
Device description
Adapter PK Working Element Gyrus PK SuperPulse System (5/PK)
Published
2016-10-18
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
FBOCYSTOURETHROSCOPE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FBOCystourethroscopeGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K021166000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K021166000ACMI BIPOLAR RECTOSCOPE, MODEL EIWE-BRAcmi-Circon Corporation2002-05-09FDC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00821925007772PackageGS15Not in Commercial Distribution
00821925038547PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00821925007772008219250077728219250077720821925007772
00821925038547008219250385478219250385470821925038547

GMDN Terms#

Term, Definition table
TermDefinition
ResectoscopeAn endoscope with a slender rigid inserted portion intended to be used to perform a resection (i.e., the electrosurgical removal of tissue within an organ). It is typically used for the transurethral resection of the prostate (TURP) for the treatment of benign prostatic hyperplasia (BPH) and removal of, e.g., myomas (fibroids) and polyps in the uterine cavity via the cervix. It typically consists of an outer sheath, a wide angle telescope, a working guide element and a variety of interchangeable electrosurgical electrodes such as a wire loop, knife, roller ball, ball and coagulating. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
007198742
Device count
1
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
00821925013964GYRUS ACMI, INC1400032015-10-24
00821925014039EVONOS GMBH & Co. Kg1400532015-10-24
00821925014060EVONOS GMBH & Co. Kg1400592015-10-24
00821925014176GYRUS ACMI, INC1400872015-10-24
00821925014190GYRUS ACMI, INC1401022015-10-24
00821925014497GYRUS ACMI, INC1401032015-10-24
00821925014534GYRUS ACMI, INC1400702015-10-24
00821925015449Gyrus ACMI1401812015-10-24
00821925015470Gyrus ACMI1401852015-10-24
00821925015487Gyrus ACMI1401862015-10-24
00821925015500GYRUS ACMI, INC1401882015-10-24
00821925016057Gyrus ACMI1401642015-10-24
00821925016064Gyrus ACMI1401652015-10-24
00821925016071Gyrus ACMI1401662015-10-24
00821925016088Gyrus ACMI1401672015-10-24
00821925016095GYRUS ACMI, INC1401682015-10-24
00821925016125Gyrus ACMI1401802015-10-24
00821925016934GYRUS ACMI, INC1401492015-10-24
00821925016965Gyrus ACMI1401622015-10-24
00821925017207GYRUS ACMI, INC1401082015-10-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04048438000175NAKarl Storz GmbH & Co. KGFBO2025-03-27
04048551431382n.a.Karl Storz GmbH & Co. KGFBO2024-11-28
04953170438158Biopsy ValveOLYMPUS MEDICAL SYSTEMS CORP.FBO2023-04-22
04953170451980Luer-Split MAJ-2092OLYMPUS MEDICAL SYSTEMS CORP.FBO2022-08-05
04055207066218E-LINERichard Wolf GmbHFBO2020-02-21
04055207066225E-LINERichard Wolf GmbHFBO2020-02-21
04055207066195E-LINERichard Wolf GmbHFBO2020-02-21
04055207066201E-LINERichard Wolf GmbHFBO2020-02-21
04048551327746n.a.Karl Storz GmbH & Co. KGFBO2019-02-23
04048551390139n.a.Karl Storz GmbH & Co. KGFBO2016-12-22
04048551390160n.a.Karl Storz GmbH & Co. KGFBO2016-12-22
04048551390184n.a.Karl Storz GmbH & Co. KGFBO2016-12-22
04048551390238n.a.Karl Storz GmbH & Co. KGFBO2016-12-22
04048551390146n.a.Karl Storz GmbH & Co. KGFBO2016-12-22
04048551390177n.a.Karl Storz GmbH & Co. KGFBO2016-12-22
00821925007772Adapter PK Working Element Gyrus® PK™ SuperPulse™ SystemGyrus Acmi, Inc.FBO2016-10-18
00821925001374Gyrus ACMIGyrus ACMI, LLCFBO2016-10-13
00821925001916USA EliteGyrus ACMI, LLCFBO2016-10-13
00821925001947Elite BipolarGyrus ACMI, LLCFBO2016-10-13
00821925011229Elite IglesiasGyrus ACMI, LLCFBO2016-10-13
00821925008229USA Elite Gyrus ACMI, LLCFBO2016-10-05
00821925008243EliteGyrus ACMI, LLCFBO2016-10-05
00821925027275Gyrus ACMIGyrus ACMI, LLCFBO2016-10-05
04055207018385NARichard Wolf GmbHFBO2016-09-29
04055207018392NARichard Wolf GmbHFBO2016-09-29
04055207018491NARichard Wolf GmbHFBO2016-09-29
04055207018194MOXYRichard Wolf GmbHFBO2016-09-27
04055207018231GREENLIGHTRichard Wolf GmbHFBO2016-09-27
04055207018255GREENLIGHTRichard Wolf GmbHFBO2016-09-27
04055207018286E-LINERichard Wolf GmbHFBO2016-09-27