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FDA 510(k)

ENDOSCOPIC MULTI-FIRE CLIP APPLIER

K-Number: K013889 · 2002-02-07

ApplicantInscope, LLC
Decision Date2002-02-07
Product CodePKL
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

ENDOSCOPIC MULTI-FIRE CLIP APPLIER is the device name listed in this FDA 510(k) record. The listed applicant is Inscope, LLC. It received FDA 510(k) clearance on 2002-02-07 under 510(k) number K013889. 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 ENDOSCOPIC MULTI-FIRE CLIP APPLIER?

ENDOSCOPIC MULTI-FIRE CLIP APPLIER is a medical device that received FDA 510(k) clearance on 2002-02-07. The listed applicant is Inscope, LLC. The 510(k) number is K013889.

When did ENDOSCOPIC MULTI-FIRE CLIP APPLIER receive FDA 510(k) clearance?

ENDOSCOPIC MULTI-FIRE CLIP APPLIER received FDA 510(k) clearance on 2002-02-07, under 510(k) number K013889.

Who is the listed applicant for ENDOSCOPIC MULTI-FIRE CLIP APPLIER?

The FDA 510(k) record lists Inscope, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ENDOSCOPIC MULTI-FIRE CLIP APPLIER?

The FDA product code for ENDOSCOPIC MULTI-FIRE CLIP APPLIER is PKL.

Related Clinical Trials

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.

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Other records listing Inscope, LLC 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.

K992477ROTOSNARE

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.

K253481colonic FTRD Set (200.70); diagnostic FTRD Set (200.76); gastroduodenal FTRD Set (200.72)Ovesco Endoscopy AGK254069Hemoclip (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 AG

Official Source

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

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