Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Lockado Repositionable Hemostasis Clip

K-Number: K202333 · 2021-01-14

ApplicantMicro-Tech (Nanjing) Co., Ltd.
Decision Date2021-01-14
Product CodePKL
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Lockado Repositionable Hemostasis Clip is the device name listed in this FDA 510(k) record. The listed applicant is Micro-Tech (Nanjing) Co., Ltd.. It received FDA 510(k) clearance on 2021-01-14 under 510(k) number K202333. The device is classified under product code PKL. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Lockado Repositionable Hemostasis Clip?

Lockado Repositionable Hemostasis Clip is a medical device that received FDA 510(k) clearance on 2021-01-14. The listed applicant is Micro-Tech (Nanjing) Co., Ltd.. The 510(k) number is K202333.

When did Lockado Repositionable Hemostasis Clip receive FDA 510(k) clearance?

Lockado Repositionable Hemostasis Clip received FDA 510(k) clearance on 2021-01-14, under 510(k) number K202333.

Who is the listed applicant for Lockado Repositionable Hemostasis Clip?

The FDA 510(k) record lists Micro-Tech (Nanjing) Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Lockado Repositionable Hemostasis Clip?

The FDA product code for Lockado Repositionable Hemostasis Clip is PKL.

Other records listing Micro-Tech (Nanjing) Co., Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K252492Visualized Access and Delivery Catheter; PB Digital ControllerK251692Advanced Tissue Resection DeviceK250229Dual Action Tissue Closure DeviceK243388Disposable Distal CapK243471Extraction BasketK230127Biliary Plastic Stent, Biliary Plastic Stent Introducer, Biliary Plastic Stent Set, Biliary Plastic Stent Introducer/ short-wire compatible, Biliary Plastic Stent Set/ short-wire compatible

View all 37 devices →

Related Devices (Code: PKL)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K254069Hemoclip (511 series, 543 series)Hangzhou AGS MedTech Co., Ltd.K260580Single Use Reloadable Clip Applicator (HX-810LR, HX-810UR); Clip (HX-610-090, HX-610-135); Long Clip (HX-610-090L, HX-610-135L); Short Clip (HX-610-090S, HX-610-135S); Super Short Clip (HX-610-135XS)Olympus Medical Systems Corp.K252270HemoclipHangzhou AGS MedTech Co., Ltd.K253734Taurus ClipTaurus EndoscopyK251562OTSCneo System Set (100.03n-14n, 100.27n-31n)Ovesco Endoscopy AGK252271HemoclipHangzhou AGS MedTech Co., Ltd.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑