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FDA 510(k)

Resolution 360™ ULTRA Clip

K-Number: K193424 · 2020-09-01

ApplicantBoston Scientific Corporation
Decision Date2020-09-01
Product CodePKL
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Resolution 360™ ULTRA Clip is the device name listed in this FDA 510(k) record. The listed applicant is Boston Scientific Corporation. It received FDA 510(k) clearance on 2020-09-01 under 510(k) number K193424. 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 Resolution 360™ ULTRA Clip?

Resolution 360™ ULTRA Clip is a medical device that received FDA 510(k) clearance on 2020-09-01. The listed applicant is Boston Scientific Corporation. The 510(k) number is K193424.

When did Resolution 360™ ULTRA Clip receive FDA 510(k) clearance?

Resolution 360™ ULTRA Clip received FDA 510(k) clearance on 2020-09-01, under 510(k) number K193424.

Who is the listed applicant for Resolution 360™ ULTRA Clip?

The FDA 510(k) record lists Boston Scientific Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Resolution 360™ ULTRA Clip?

The FDA product code for Resolution 360™ ULTRA Clip is PKL.

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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.

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