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Kumar Clamp® for Single Port, Bariatrics and Robotics

FDA UDI

Class I (US FDA UDI)

by Nashville Surgical Instruments

Identity

Trade Name
Kumar Clamp® for Single Port, Bariatrics and Robotics FDA UDI
Generic Name
Laparoscopic tissue manipulation forceps/working-channel FDA UDI
Device Name
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. FDA UDI
Model / Reference
KC2XL FDA UDI
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. FDA UDI

Identifiers

Catalog Number
KC-2XL FDA UDI
Primary DI / UDI-DI
B361KC2XL0 FDA UDI
510(k) Number
K973621 FDA UDI
FDA Product Code
GBZ FDA UDI
GMDN Term
Laparoscopic tissue manipulation forceps/working-channel FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
878.4200 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

Yes

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Dimensions & Sizes

Size
Outer Diameter — 5 Millimeter FDA UDI
Length — 45 Centimeter FDA UDI

Category: Laparoscopic tissue manipulation forceps/working-channel

Kumar Clamp® for Single Port, Bariatrics and Robotics by Nashville Surgical Instruments — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Laparoscopic tissue manipulation forceps/working-channel.

Cleared under the same submission

K973621 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Nashville Surgical Instruments

Sources (1)

  • FDA UDI 2280888e-6e5a-4011-8c93-d7b3782c8c11 37 fields · synced May 30, 2026