FDA.reportPublic FDA data

MIP Minimal Invasive PCNL

Primary DI
04048551366660
Brand
MIP Minimal Invasive PCNL
Company
Karl Storz GmbH & Co. KG
Model
27840KA
Device description
Nephroscope for MIP L
Published
2019-02-23
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
FGAKit, nephroscope

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FGAKit, NephroscopeGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K940594000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K940594000KARL STORZ ADULT & PEDIATRIC NEPHROSCOPEKARL STORZ Endoscopy-America, Inc.1994-09-09FGA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04048551366660PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04048551366660040485513666604048551366660

GMDN Terms#

Term, Definition table
TermDefinition
Rigid optical nephroscopeAn endoscope with a rigid inserted portion intended for the visual examination and treatment of the kidney. It is inserted percutaneously into the renal pelvis during nephroscopy. Anatomical images are transmitted to the user through relayed lens optics or a fibreoptic bundle. This device is typically used to examine the internal structures of the kidney and may be used in the removal of renal calculi. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
315731430
Device count
1
Serial number
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04048551001141n.a.495NCS2016-09-23
04048551004401n.a.495TIP2016-09-23
04048551004463n.a.50200FFL2018-08-21
04048551028568n.a.495ADM2016-09-23
04048551049549n.a.10970AE2018-08-17
04048551049563n.a.10970BE2018-08-17
04048551052495n.a.12016EM2016-09-23
04048551052525n.a.12016FM2016-09-23
04048551052990n.a.12061A2016-09-23
04048551053003n.a.12061AU2016-09-23
04048551053010n.a.12061AV2016-09-23
04048551053027n.a.12061AW2016-09-23
04048551053034n.a.12061AX2016-09-23
04048551053041n.a.12061B2016-09-23
04048551053065n.a.12061C2016-09-23
04048551053072n.a.12061F2016-09-23
04048551053089n.a.12061G2016-09-23
04048551053096n.a.12061H2016-09-23
04048551053102n.a.12061K2016-09-23
04048551082027n.a.233250B2016-09-23

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Primary DI, Brand, Company table
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06925816657542ClearPetraWell Lead Medical Co.,LtdFGA2026-01-26
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06925816657603ClearPetraWell Lead Medical Co.,LtdFGA2026-01-26
06925816657610ClearPetraWell Lead Medical Co.,LtdFGA2026-01-26
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06925816657634ClearPetraWell Lead Medical Co.,LtdFGA2026-01-26
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06925816657658ClearPetraWell Lead Medical Co.,LtdFGA2026-01-26
06925816657665ClearPetraWell Lead Medical Co.,LtdFGA2026-01-26
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06925816657702ClearPetraWell Lead Medical Co.,LtdFGA2026-01-26
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06925816657726ClearPetraWell Lead Medical Co.,LtdFGA2026-01-26
06925816657733ClearPetraWell Lead Medical Co.,LtdFGA2026-01-26
06925816657740ClearPetraWell Lead Medical Co.,LtdFGA2026-01-26
00810143891294Strauss SurgicalAMERICAN MEDICAL ENDOSCOPY, INC.FGA2025-04-25
04055207038666NARichard Wolf GmbHFGA2024-04-01