Who else makes this device?

Name: Pediatric Bone Marrow Needle
Brand: Pediatric Bone Marrow Needle

Gastroenterology & Urology › DiagnosticInstrument, Biopsy

Pediatric Bone Marrow Needle

Pediatric Bone Marrow Needle 18ga x 3.58cm

Registry build 21.09.26

9manufacturers in China registered for this device type

1catalogue number

2510(k) clearances naming this product code

11recalls on this code

Who Else Makes It

Concentrated in Zhejiang (4), Jiangsu (3), Guangdong (1). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code KNW
Manufacturer	City	Province	Registered as	Device types
Zhejiang Curaway Medical Technology Co., Ltd.	Hangzhou	Zhejiang	Contract manufacturer	7
Plexus (Xiamen) Co., Ltd.,	Xiamen	Fujian	Contract manufacturer	3
Micro-Tech (Nanjing) Co., Ltd.	Nan Jing	Jiangsu	Contract manufacturer	49
Zhejiang Huanyi Sterilization Technology Co., Ltd.	Huzhou	Zhejiang	Contract manufacturer	25
Jiana Sterilization Technology (Hangzhou) Co., Ltd.	Hangzhou	Zhejiang	Contract manufacturer	23
Promisemed Hangzhou Meditech Co., Ltd.	Hangzhou	Zhejiang	Contract manufacturer	21
Carbon (Shenzhen) Medical Device Co., Ltd.	Shenzhen	Guangdong	Manufacturer	6
Canyon Medical Inc.	Nanjing	Jiangsu	Manufacturer	4
Suzhou Leapmed Healthcare Corporation	Suzhou	Jiangsu	Contract manufacturer	3

Record

Regulatory record for Pediatric Bone Marrow Needle
Listed by	Argon Medical Devices, Inc., United States
FDA product code	KNW
Device type	Instrument, Biopsy
Device class	Class 2
Regulation	21 CFR 876.1075
Establishment	Contract manufacturer, Specification developer, Repacker / relabeller, Manufacturer
Record published	2016-09-20
Record revised	2026-05-11 (version 4)

Specifications

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

Catalogue Numbers

Catalogue numbers for Pediatric Bone Marrow Needle
Catalogue number	Size	Status
ION18015	18ga x 3.58cm	In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Curaway	Zhejiang Curaway Medical Technology Co., Ltd.	910
SureAim Coaxial Biopsy Needle	Canyon Medical Inc.	157
CorVocet™	Merit Medical Systems, Inc.	157
SureCore Automatic Disposable Biopsy Needle	Canyon Medical Inc.	156
M Biopsy Automatic Disposable Biopsy Needle	Canyon Medical Inc.	108
M Biopsy Coaxial Biopsy Needle	Canyon Medical Inc.	89
Co-Axial Introducer Needle	Argon Medical Devices, Inc.	80
SureCore Semi-automatic Disposable Biopsy Needle	Canyon Medical Inc.	76
Invivo	Philips DS North America LLC	71
Coaxial needle	Möller Medical GmbH	68
Disposable needle for reusable biopsy gun	Möller Medical GmbH	62
Remington Medical, Inc. Automatic Cutting Needle (NAC)	Remington Medical, Inc.	60

Showing 12 of 692. All products under Instrument, Biopsy

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance	Decision date
K252795	2026-02-23
K213232	2022-07-01

Recalls

3 of these are Class I. Class I is the FDA’s most serious grade: a reasonable probability of serious injury or death. 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
2026-06-01	Class I	Material/Component Contamination	Kits containing Lidocaine HCL Injection USP 1% 10mg/mL 5mL ampules subject to another recall recalled due to not meeting release criteria for sterility.	1800
2026-06-01	Class I	Material/Component Contamination	Kits containing Lidocaine HCL Injection USP 1% 10mg/mL 5mL ampules subject to another recall recalled due to not meeting release criteria for sterility.	680
2026-06-01	Class I	Material/Component Contamination	Kits containing Lidocaine HCL Injection USP 1% 10mg/mL 5mL ampules subject to another recall recalled due to not meeting release criteria for sterility.	850
2024-07-02	Class II	Packaging change control	Holes have been identified in biopsy instrument packaging trays compromising the sterile barrier, which may lead to cross contamination, or the introduction of micro-organisms into the access site, which could lead to an infectious process,	95,430
2021-10-04	Class II	Device Design	Due to component (housing and plunger) detaching from the semi-automatic biopsy instruments.	79,910 devices
2019-12-02	Class II	Labeling Change Control	Incorrect product labeling.	165 units in U.S. and 330 units Internationally	2022-11-09
2017-01-18	Class II	Equipment maintenance	The recalling firm received a complaint from one of their customers of a potential defect in the forming of the primary package of the blister that may compromise the sterility of the product inside the tray.	497 boxes	2017-05-17
2017-01-18	Class II	Equipment maintenance	The recalling firm received a complaint from one of their customers of a potential defect in the forming of the primary package of the blister that may compromise the sterility of the product inside the tray.	772 boxes	2017-05-17
2017-01-18	Class II	Equipment maintenance	The recalling firm received a complaint from one of their customers of a potential defect in the forming of the primary package of the blister that may compromise the sterility of the product inside the tray.	15 boxes	2017-05-17
2015-06-18	Class II	Packaging process control	Potential defect in the forming of the primary package of the blister that may compromise the sterility of the product inside the tray.	6390 units	2016-06-23
2015-06-18	Class II	Packaging process control	Potential defect in the forming of the primary package of the blister that may compromise the sterility of the product inside the tray.	10290 units	2016-06-23

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.