SureClip Repositionable Hemostasis Clip

Hemostatic Metal Clip For The Gi Tract

Micro-Tech (Nanjing) CO., Ltd.

The following data is part of a premarket notification filed by Micro-tech (nanjing) Co., Ltd. with the FDA for Sureclip Repositionable Hemostasis Clip.

Pre-market Notification Details

Device IDK182556
510k NumberK182556
Device Name:SureClip Repositionable Hemostasis Clip
ClassificationHemostatic Metal Clip For The Gi Tract
Applicant Micro-Tech (Nanjing) CO., Ltd. NO. 10 Gaoke Third Road Nanjing,  CN 210032
ContactBecky Li
CorrespondentBecky Li
Micro-Tech (Nanjing) CO., Ltd. NO. 10 Gaoke Third Road Nanjing,  CN 210032
Product CodePKL  
CFR Regulation Number876.4400 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2018-09-17
Decision Date2018-12-14
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
16932503530467 K182556 000
16932503530528 K182556 000
16932503530535 K182556 000
16932503530542 K182556 000
16932503530399 K182556 000
16932503530405 K182556 000
16932503530412 K182556 000
16932503530429 K182556 000
16932503530436 K182556 000
16932503530443 K182556 000
16932503530450 K182556 000
16932503530511 K182556 000

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