FDA.reportPublic FDA data

Kumar Clamp® for Single Port, Bariatrics and Robotics

Primary DI
B361KC2XL0
Brand
Kumar Clamp® for Single Port, Bariatrics and Robotics
Company
NASHVILLE SURGICAL INSTRUMENTS, LLC
Model
KC2XL
Catalog number
KC-2XL
Device description
The Kumar Clamp® for Single Port, Bariatrics and Robotics is a reusable 5mm stainless steel laparoscopic grasper of 45 cm length with long ( 3.8 cm) atraumatic jaws and a channel for introduction of the single use Kumar Catheter®. The system is meant to provide a method of laparoscopic cholangiography.
Published
2017-08-15
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GBZCatheter, Cholangiography

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GBZCatheter, CholangiographyGeneral, Plastic Surgery1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K973621000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K973621000PRE-VIEW CHOLANGIOGRAPHY CLAMPNashville Surgical Instruments1997-12-17GBZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B361KC2XL0PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Laparoscopic grasping forceps/working-channelA manually-powered, rigid, surgical instrument designed to be introduced through a laparoscope for: 1) atraumatic grasping/clamping of soft tissues (e.g., gallbladder); and 2) access adjacent to the site of clamping (e.g., during laparoscopic cholangiography). It is a hand-held device with proximal handles, a long slender shaft with a built-in working-channel, and distal grasping blades. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length45Centimeter
Outer Diameter5Millimeter

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
615-382-4996orders@nashvillesurg.com

Regulatory Flags#

DUNS number
030096122
Device count
1
DM exempt
true
Combination product
true
Lot or batch
true
No natural rubber latex
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B361CC0190Kumar Catheter®CC019CC-0192017-08-15
B361KC0020Kumar Clamp®KC-002KC-0022017-08-15
B361TA0080Kumar T-ANCHORS® Hernia SetTA-008TA-0082017-08-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810158211872PRINCETONPrinceton Medical Group, Inc.GBZ2024-07-30
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04049197181631Guyon Catheters RZ-Medizintechnik GmbHGBZ2023-08-16
04049197264310Metal CatheterRZ-Medizintechnik GmbHGBZ2023-08-16
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04049197466059FOLEY CatheterRZ-Medizintechnik GmbHGBZ2023-08-16
04049197466080Rotunda KatheterRZ-Medizintechnik GmbHGBZ2023-08-16
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