RiteClip(TM) Repositionable Hemostasis Clip

FDA UDI

Class II (US FDA UDI)

by Micro-Tech (Nanjing) Co., Ltd.

Identity

Trade Name: RiteClip(TM) Repositionable Hemostasis Clip FDA UDI
Generic Name: Gastrointestinal endoscopic clip, short-term FDA UDI
Device Name: Open width8+2/0mm the max OD of insertion part 2.6mm working length 1950mm uncoated. FDA UDI
Model / Reference: ROCC-C-26-195 FDA UDI
Description: Open width8+2/0mm the max OD of insertion part 2.6mm working length 1950mm uncoated. FDA UDI

Identifiers

Primary DI / UDI-DI: 06932503530699 FDA UDI
510(k) Number: K161463 FDA UDI
FDA Product Code: PKL FDA UDI
GMDN Term: Gastrointestinal endoscopic clip, short-term FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 876.4400 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

MRI Safety

MR Conditional FDA UDI

Dimensions & Sizes

Size: Length — 195 Centimeter FDA UDI
Outer Diameter — 2.6 Millimeter FDA UDI

Category: Gastrointestinal endoscopic clip, short-term

RiteClip(TM) Repositionable Hemostasis Clip by Micro-Tech (Nanjing) Co., Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Gastrointestinal endoscopic clip, short-term.

ZKSK — Beijing ZKSK Technology Co., Ltd · Class II
Disposable Hemostatic Clips — Ningbo Xinwell Medical Technology Co., Ltd. · Class II
DuraClip(TM) Repositionable Hemostasis Clip — Transmed (China) Co., Ltd. · Class II
Disposable Hemostatic Clips — Ningbo Xinwell Medical Technology Co., Ltd. · Class II
Disposable Hemostatic Clips — Ningbo Xinwell Medical Technology Co., Ltd. · Class II
ZKSK — Beijing ZKSK Technology Co., Ltd · Class II
Disposable Hemostatic Clips — Ningbo Xinwell Medical Technology Co., Ltd. · Class II
Disposable Hemostatic Clips — Ningbo Xinwell Medical Technology Co., Ltd. · Class II

Cleared under the same submission

K161463 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Micro-Tech (Nanjing) Co., Ltd.

Sources (1)

FDA UDI e6ebd6b8-2db3-44fd-a211-c36a38fbde47 36 fields · synced May 30, 2026