510(k) clearances

Disposable Hemostatic Clips

Zhejiang Soudon Medical Technology Co., Ltd. · Gastroenterology, Urology

K232450Substantially EquivalentTraditionalPKL
Open FDA's page for this record
Third party flag
N
City
Hangzhou
Advisory committee description
Gastroenterology, Urology
Address 1
Rm. 302-1, Floor 3, Bldg. 4, #1 Nangonghe Rd.,
Address 2
Donghu St., Linping District
Statement or summary
Summary
Product code
PKL
Zip code
311100
Applicant
Zhejiang Soudon Medical Technology Co., Ltd.
Decision date
2024-01-26
Decision code
SESE
Country code
CN
Device name
Disposable Hemostatic Clips
Advisory committee
GU
Contact
Junshi Wang
K number
K232450
Date received
2023-08-14
Review advisory committee
GU
Postal code
311100
Decision description
Substantially Equivalent
Clearance type
Traditional
Harmonized identifiers (openFDA)
Device name
Hemostatic Metal Clip For The Gi Tract
Medical specialty description
Gastroenterology, Urology
Regulation number
876.4400
Device class
2
Registration number
3011050570, 3030446844, 9611680, 3010288205, 3035434483, 1000121056, 3014769442, 3021023752, 3017210488, 3030733800, 8010047, 3008720584, 3044854047, 3013460719, 3010515547, 3007695959, 3015142721, 2183446, 3033841914, 3013440400, 9614641, 1061927, 3010273872, 3017178358, 1047843, 3009217531, 1528319, 3009747810, 3013526170, 3014328942, 3008797804, 3004837686, 9681260, 3005099803, 3025311469, 3007829657, 3010432890, 3012494290, 3036773433, 3006621103 +14 more
FEI number
3011050570, 3030446844, 3010288205, 3002807969, 3035434483, 1000121056, 3002806565, 3014769442, 3021023752, 3017210488, 3030733800, 3008720584, 1000132436, 3044854047, 3013460719, 3010515547, 3007695959, 3000203000, 3015142721, 3002807795, 3033841914, 3013440400, 2183446, 3010273872, 3002806816, 3017178358, 1047843, 3009217531, 3009747810, 3013526170, 3003995201, 3014328942, 3008797804, 3004837686, 3005099803, 3025311469, 3007829657, 3010432890, 3012494290, 1000122656 +14 more
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Data from openFDA, FDA's public API. FDA says not to rely on it to make decisions about medical care and to treat every result as unvalidated; confirm against FDA's own record and the product labeling. Not medical or legal advice.