Who else makes this device?

Name: TAP Tubing Set
Brand: TAP Tubing Set

TAP Tubing Set · Insufflator, Laparoscopic → Obstetrics & Gynecology

10manufacturers in China registered for this device type

1catalogue number

16510(k) clearances naming this product code

2recalls on this code

Who Else Makes It

Concentrated in Zhejiang (4), Guangdong (3), Jiangsu (2). One is registered as a contract manufacturer, able to build to a specification.

Chinese manufacturers registered for FDA product code HIF
Manufacturer	City	Province	Registered as	Device types
Guangzhou T.K Medical Instrument Co., Ltd.	Guangzhou	Guangdong	Contract manufacturer	7
Hangzhou Kangji Medical Instrument Co., Ltd.	Hangzhou	Zhejiang	Contract manufacturer	27
Goals Sterilization Co., Ltd.	Jiaxing	Zhejiang	Contract manufacturer	26
Wuxi Goals Medical Technology Co., Ltd.	Yixing	Jiangsu	Contract manufacturer	24
Scivita Medical Technology Co., Ltd.	Suzhou	Jiangsu	Manufacturer	19
Global Medical Production Co., Ltd.	Jiaxing	Zhejiang	Manufacturer	10
Surgnova Healthcare Technologies (Zhejiang) Co., Ltd.	Cixi	Zhejiang	Manufacturer	8
Guangdong Optomedic Technologies, Inc.	Foshan	Guangdong	Manufacturer	7
Unimicro Medical Systems (Shenzhen) Co., Ltd.	Shenzhen	Guangdong	Manufacturer	6
Tianjin Uwell Medical Device Manufacturing Co Ltd	Tianjin	Tianjin	Manufacturer	3

Record

Regulatory record for TAP Tubing Set
Listed by	Northgate Technologies Inc., United States
FDA product code	HIF
Device type	Insufflator, Laparoscopic
Device class	Class 2
Regulation	21 CFR 884.1730
Establishment	Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer
510(k)	K983326
Record published	2016-10-14
Record revised	2022-06-10 (version 5)

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Supplied sterile	Yes
Single use	Yes
Prescription	Prescription only
Latex	Contains natural rubber latex
Label carries	lot or batch number, expiry date, manufacturing date
Packaging	Pack of 10

Catalogue Numbers

Catalogue numbers for TAP Tubing Set
Catalogue number	Size	Status
7-510-31		In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Comeg Medical	Sopro	20
Insufflator, Laparoscopic	Richard Wolf Gmbh	19
Airseal	ConMed Corporation	10
Insufflator, Laparoscopic	Smith & Nephew, Inc.	10
Gimmi	Gimmi Gmbh	8
Insuflow Port	Lexion Medical, LLC.	8
Aesculap	Aesculap AG	7
Insufflator, Laparoscopic	Stryker GmbH	6
EVA15	Palliare	6
Conmed	ConMed Corporation	6
Pneumosure	Stryker GmbH	6
Diversatek Healthcare	Diversatek Healthcare Inc	6

Showing 12 of 114. All products under Insufflator, Laparoscopic

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance	Decision date
K120151	2012-08-17
K041560	2004-09-28
K033614	2004-07-29
K022052	2003-01-24
K010053	2001-10-23
K992381	1999-09-17
K983326	1999-02-05
K973447	1998-09-30
K972675	1998-09-30
K935862	1994-08-19
K915051	1992-06-04
K914403	1991-11-27
K914401	1991-11-27
K914402	1991-11-27
K911179	1991-11-13
K905481	1991-03-29

Recalls

2 of these are Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.

Recalls referencing this product code
Initiated	FDA class	Root cause	Reason	Quantity	Closed
2021-01-15	Class II	Nonconforming Material/Component	An internal tubing component in the flow path was made with incorrect material which was not tested for use with this device.	25 units	2022-10-31
2016-11-21	Class II	Software design	Device could cause a patient overpressure situation without any visual or auditory indication or warning	49 devices	2017-11-27

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.

TAP Tubing Set