FDA.reportPublic FDA data

n.a.

Primary DI
04048438005392
Brand
n.a.
Company
Karl Storz GmbH & Co. KG
Model
011160-10
Catalog number
011160-10
Device description
Electrode, bipolar
Published
2024-10-04
Public version status
New
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
K221893000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K221893000KARL STORZ Bipolar Resectoscopes with HF CableKarl Storz Endoscopy America, Inc.2023-03-17FJL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04048438005408PrimaryGS10
04048438005392Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04048438005408040484380054084048438005408
04048438005392040484380053924048438005392

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
315731430
Device count
10
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
04048551158913n.a.40107A40107A2026-11-04
04048551158937n.a.40107B40107B2026-11-04
04048551423509n.a.28272TM28272TM2026-11-04
04048551430521n.a.28272TLS28272TLS2026-11-04
04048551425671NA26606ACA26606ACA2025-03-27
04048551425688NA26606BCA26606BCA2025-03-27
04048551426166NA26616BCA26616BCA2025-03-27
04048551426180NA26616ACA26616ACA2025-03-27
04048551102503n.a.26183MA26183MA2018-07-21
04048551102527n.a.26183MB26183MB2018-07-21
04048551393086n.a.26183MC-S26183MC-S2016-09-23
04048551393567n.a.26183MD-S26183MD-S2016-09-23
04048551279618n.a.20701070207010702026-11-02
04048551414613n.a.28272TL28272TL2026-11-02
04048551431603n.a.UM600UM6002026-11-02
04048551432822ENDOMAT SELECTUP220UP2202026-11-02
04048551454121ARTip CRUISEUR502UR5022026-11-02
04048551453469n.a.UI600UI6002026-10-29
04048551458785n.a.TS100TS1002026-10-28
04048551343425n.a.28729KLT2019-02-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810116023776Dornier MedTechDORNIER MEDTECH AMERICA, INC.FAS2026-10-05
00810116023790Dornier MedTechDORNIER MEDTECH AMERICA, INC.FAS2026-10-05
00810116023806Dornier MedTechDORNIER MEDTECH AMERICA, INC.FAS2026-10-05
00810116023813Dornier MedTechDORNIER MEDTECH AMERICA, INC.FAS2026-10-05
00810116023851Dornier MedTechDORNIER MEDTECH AMERICA, INC.FAS2026-10-05
00810116023875Dornier MedTechDORNIER MEDTECH AMERICA, INC.FAS2026-10-05
00810116023899Dornier MedTechDORNIER MEDTECH AMERICA, INC.FAS2026-10-05
00810143893137Strauss SurgicalAMERICAN MEDICAL ENDOSCOPY, INC.FAS2026-07-21
00810143893144Strauss SurgicalAMERICAN MEDICAL ENDOSCOPY, INC.FAS2026-07-21
00810143893151Strauss SurgicalAMERICAN MEDICAL ENDOSCOPY, INC.FAS2026-07-21
00810143893168Strauss SurgicalAMERICAN MEDICAL ENDOSCOPY, INC.FAS2026-07-21
00810143893175Strauss SurgicalAMERICAN MEDICAL ENDOSCOPY, INC.FAS2026-07-21
00810143893182Strauss SurgicalAMERICAN MEDICAL ENDOSCOPY, INC.FAS2026-07-21
00810143893199Strauss SurgicalAMERICAN MEDICAL ENDOSCOPY, INC.FAS2026-07-21
00810143893205Strauss SurgicalAMERICAN MEDICAL ENDOSCOPY, INC.FAS2026-07-21
00810143893212Strauss SurgicalAMERICAN MEDICAL ENDOSCOPY, INC.FAS2026-07-21
00810143893229Strauss SurgicalAMERICAN MEDICAL ENDOSCOPY, INC.FAS2026-07-21
00810143893236Strauss SurgicalAMERICAN MEDICAL ENDOSCOPY, INC.FAS2026-07-21
00810143893243Strauss SurgicalAMERICAN MEDICAL ENDOSCOPY, INC.FAS2026-07-21
00810143893250Strauss SurgicalAMERICAN MEDICAL ENDOSCOPY, INC.FAS2026-07-21
00810143893267Strauss SurgicalAMERICAN MEDICAL ENDOSCOPY, INC.FAS2026-07-21
00810143893274Strauss SurgicalAMERICAN MEDICAL ENDOSCOPY, INC.FAS2026-07-21
00810143893281Strauss SurgicalAMERICAN MEDICAL ENDOSCOPY, INC.FAS2026-07-21
00810143893298Strauss SurgicalAMERICAN MEDICAL ENDOSCOPY, INC.FAS2026-07-21
00810143893304Strauss SurgicalAMERICAN MEDICAL ENDOSCOPY, INC.FAS2026-07-21
00810143893311Strauss SurgicalAMERICAN MEDICAL ENDOSCOPY, INC.FAS2026-07-21
00810143893007Strauss SurgicalAMERICAN MEDICAL ENDOSCOPY, INC.FAS2026-07-20
00810143893014Strauss SurgicalAMERICAN MEDICAL ENDOSCOPY, INC.FAS2026-07-20
00810143893021Strauss SurgicalAMERICAN MEDICAL ENDOSCOPY, INC.FAS2026-07-20
00810143893038Strauss SurgicalAMERICAN MEDICAL ENDOSCOPY, INC.FAS2026-07-20