Who else makes this device?

Name: Kumar Clamp®
Brand: Kumar Clamp®

General & Plastic Surgery › SurgicalCatheter, Cholangiography

Kumar Clamp®

The Kumar Clamp® is a reusable 5mm stainless steel laparoscopic grasper of 37 cm length with long ( 3.8 cm) atraumatic jaws and a channel for introduction of the single use Kumar Catheter®.…

Registry build 21.09.26

The Kumar Clamp® is a reusable 5mm stainless steel laparoscopic grasper of 37 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.

1manufacturer

1catalogue number

1510(k) clearance

Who Else Makes It

Registered in Zhejiang. One is registered as a contract manufacturer, able to build to a specification.

Chinese manufacturers registered for FDA product code GBZ
Manufacturer	City	Province	Registered as	Device types
Beilun Plastech Inc	Ningbo	Zhejiang	Contract manufacturer	13

Record

Regulatory record for Kumar Clamp®
Listed by	Nashville Surgical Instruments, United States
FDA product code	GBZ
Device type	Catheter, Cholangiography
Device class	Class 1
Regulation	21 CFR 878.4200
Establishment	Specification developer, Manufacturer
510(k)	K973621
Record published	2017-08-15
Record revised	2019-08-21 (version 4)

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Sterilisation	Moist Heat or Steam Sterilization
Prescription	Prescription only
Latex	Labelled latex-free
Label carries	lot or batch number
Sizes	Outer diameter 5 mm; length 37 cm
UDI direct marking	Exempt

Catalogue Numbers

Catalogue numbers for Kumar Clamp®
Catalogue number	Size	Status
KC-002	Outer Diameter 5 mm	In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Taut	Teleflex Medical LLC	31
PVC Thoracic Catheters	Atrium Medical Corporation	30
Cook	Cook Incorporated	12
Reddick Scoop Tip Cholangiogram Catheter	Lemaitre Vascular, Inc.	8
Symmetry Surgical	Aspen Surgical Products, Inc.	8
PMI	Progressive Medical Technology, Inc.	8
Reddick Cholangiogram Catheter	Lemaitre Vascular, Inc.	7
Olsen	Cook Incorporated	7
Princeton	Princeton Medical Group, Inc.	3
RX Ercp Cannula	Boston Scientific Corporation	2
Metal Catheter	RZ Medizintechnik Gmbh	2
Catheter, Cholangiography	Edwards Lifesciences Technology Sarl	2

Showing 12 of 32. All products under Catheter, Cholangiography

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance	Decision date
K973621	1997-12-17

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.