Who else makes this device?

Name: Acucise® Procedural Pack Starter Pack
Brand: Acucise® Procedural Pack Starter Pack

Gastroenterology & Urology › TherapeuticAccessories, Catheter, G-U

Acucise® Procedural Pack Starter Pack

Kit Contains: B1005, ACUCISE® ENDOPYELOTOMY SYSTEM B1201, URO TAMPONADE BALLOON CATH B3304, STENT, C-FLEX 7/10F x 24 CM B3301, STENT, C-FLEX, 7/10F X 26CM B3302, STENT, C-FLEX, 7/10F X 28CM…

Registry build 21.09.26

Kit Contains: B1005, ACUCISE® ENDOPYELOTOMY SYSTEM B1201, URO TAMPONADE BALLOON CATH B3304, STENT, C-FLEX 7/10F x 24 CM B3301, STENT, C-FLEX, 7/10F X 26CM B3302, STENT, C-FLEX, 7/10F X 28CM B3303, STENT, C-FLEX, 7/10F X 30CM B7016, FORTE AxP SET 12/14/18F 35CM 6/BX

1manufacturer

1catalogue number

1510(k) clearance

Who Else Makes It

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

Chinese manufacturers registered for FDA product code KNY
Manufacturer	City	Province	Registered as	Device types
Conod Medical Shuyang Co., Ltd.	Shuyang	Jiangsu	Contract manufacturer	22

Record

Regulatory record for Acucise® Procedural Pack Starter Pack
Listed by	Applied Medical Resources Corp., United States
FDA product code	KNY
Device type	Accessories, Catheter, G-U
Device class	Class 2
Regulation	21 CFR 876.5130
Establishment	Contract manufacturer, Complaint-file establishment, Manufacturer
Record published	2015-10-09
Record revised	2024-12-23 (version 5)

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Supplied sterile	Yes
Single use	Yes
Prescription	Prescription only
Supplied as a kit	Yes
Latex	Labelled latex-free
Label carries	lot or batch number, expiry date
Distribution end date	2018-07-13

Catalogue Numbers

Catalogue numbers for Acucise® Procedural Pack Starter Pack
Catalogue number	Size	Status
BK001		Withdrawn

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
UroPass	Gyrus Acmi, Inc.	15
Ureteral Access Sheath with 2, 3 Fr working channels dilator, 10Frx45cm	Promepla	4
Dover	Cardinal Health 200, LLC	3
Silhouette® Pediatric Ureteral Stent with Urowire® Guidewire	Applied Medical Resources Corp.	3
UroWire® Guidewire with SL-6® Hydrophilic Coating	Applied Medical Resources Corp.	2
BI-Flex Access Sheath – 12 inner / 14 outer – Length 45cm	Promepla	1
Gyrus Acmi, Inc	Gyrus Acmi, Inc.	1
Acucise® Custom KIT	Applied Medical Resources Corp.	1
Bard® “C” Clamp	C.R. Bard, Inc.	1
Acucise® Procedural Pack Universal Pack C	Applied Medical Resources Corp.	1
Bi-Flex	Promepla	1
Bard® Drainage Protector and Catheter Plug	C.R. Bard, Inc.	1

Showing 12 of 28. All products under Accessories, Catheter, G-U

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance	Decision date
K944135	1994-09-21

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.