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FDA 510(k)

ROTOSNARE

K-Number: K992477 · 1999-08-24

ApplicantInscope, LLC
Decision Date1999-08-24
Product CodeFDI
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

ROTOSNARE is the device name listed in this FDA 510(k) record. The listed applicant is Inscope, LLC. It received FDA 510(k) clearance on 1999-08-24 under 510(k) number K992477. The device is classified under product code FDI. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ROTOSNARE?

ROTOSNARE is a medical device that received FDA 510(k) clearance on 1999-08-24. The listed applicant is Inscope, LLC. The 510(k) number is K992477.

When did ROTOSNARE receive FDA 510(k) clearance?

ROTOSNARE received FDA 510(k) clearance on 1999-08-24, under 510(k) number K992477.

Who is the listed applicant for ROTOSNARE?

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 ROTOSNARE?

The FDA product code for ROTOSNARE is FDI.

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.

K013889ENDOSCOPIC MULTI-FIRE CLIP APPLIER

Related Devices (Code: FDI)

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.

K251692Advanced Tissue Resection DeviceMicro-Tech (Nanjing) Co., Ltd.K221713Polypectomy SnareHangzhou AGS MedTech Co., Ltd.K220846CORE-SNAREIncore Co., Ltd.K220089Disposable Polyp SnareJiangsu Vedkang Medical Science and Technology Co., Ltd.K220790Disposable Polypectomy Snare, Disposable Polypectomy Hybrid SnareYangzhou Fartley Medical Instrument Technology Co., Ltd.K213222Disposable Polypectomy SnareBeijing Zksk Technology Co., Ltd.

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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