What is FDA product code LRO?

This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance

Large Volume Paracentesis Kit · General Surgery Tray → General & Plastic Surgery

Name: Large Volume Paracentesis Kit
Brand: Large Volume Paracentesis Kit

24manufacturers in China registered for this device type

1catalogue number

1510(k) clearance

1recall

Who Else Makes It

Concentrated in Jiangsu (11), Anhui (6), Zhejiang (4). 9 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code LRO
Manufacturer	City	Province	Registered as	Device types
Conod Medical Co., Limited	Changshu	Jiangsu	Contract manufacturer	48
Principle & Will Biotech (Pinghu) Co., Ltd.	Pinghu	Zhejiang	Contract manufacturer	39
Sino Protection (Hefei) Medical Products Co., Ltd.	Hefei	Anhui	Contract manufacturer	18
Changzhou Holymed Products Co., Ltd.	Changzhou	Jiangsu	Contract manufacturer	16
Donghai Xingchen NON-Woven Products Co., Ltd.	North Donghai Development Zone, Lianyungang	Jiangsu	Contract manufacturer	7
Fengyang Jiehong Nonwoven Product Co., Ltd.	Chuzhou	Anhui	Contract manufacturer	7
3A Medical Products Co., Ltd.	Liu An	Anhui	Contract manufacturer	6
Cobes Industries (Jinzhai) Co., Ltd.	Luan	Anhui	Contract manufacturer	6
Lianyungang Aiyeh Non-woven Products Co., Ltd.	Lianyungang	Jiangsu	Contract manufacturer	6
Jiangsu NEW Pentastar Medical Products Co., Ltd.	Changzhou	Jiangsu	Exporter	146
Ningbo Greetmed Medical Instruments Co., Ltd.	Ningbo	Zhejiang	Specification developer	75
GRI Medical & Electronic Technology Co., Ltd.	Jiaxing	Zhejiang	Contract manufacturer	71

Showing 12 of 24. All 24 manufacturers in China registered for General Surgery Tray

Record

Regulatory record for Large Volume Paracentesis Kit
Listed by	GI Supply, United States
FDA product code	LRO
Device type	General Surgery Tray
Device class	Class 2
Regulation	21 CFR 878.4370
Establishment	Specification developer, Complaint-file establishment, Manufacturer
510(k)	K970187
Record published	2016-09-24
Record revised	2021-07-07 (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
Label carries	lot or batch number, expiry date
Storage	Storage environment temperature 20 to 25 °C
Packaging	Box of 5
Distribution end date	2018-08-03

Catalogue Numbers

Catalogue numbers for Large Volume Paracentesis Kit
Catalogue number	Size	Status
GIS-28		Withdrawn

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Cardinal Health	Cardinal Health 200, LLC	67,931
Medline Industries, Inc.	Medline Industries, Inc.	54,362
Avid TruCustom	Avid Medical, Inc.	13,498
Halyard	Avid Medical, Inc.	12,802
ACS	American Contract Systems, Inc.	10,337
SurgiTrack	Owens & Minor Distribution, Inc.	5,575
Aligned Medical Solutions	Aligned Medical Solutions	3,490
SurgiTrackSM	Owens & Minor Distribution, Inc.	3,364
DeRoyal	Deroyal Industries, Inc.	2,770
Medline	Medline Industries, Inc.	1,960
Henry Schein	Henry Schein, Inc.	729
Stradis	Stradis Healthcare	685

Showing 12 of 113. All products under General Surgery Tray

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance	Decision date
K970187	1997-02-14

Recalls Naming This Product

1 recall names this product by its own identifier, the 510(k) it is cleared under.

Recalls naming the identifiers of Large Volume Paracentesis Kit
Recalled by	Identified by	Initiated	FDA class	Root cause	Reason	Quantity	Closed
GI Supply	510(k) number	2016-01-28	Class II	Nonconforming Material/Component	Customers have reported that the pinch clamp on the RP Bag was missing. Ascetic fluid from the abdominal cavity may splash User if bag is not clamped prior to removal.	390 Kits	2016-12-07

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.

Large Volume Paracentesis Kit