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FDA 510(k)

TORNADO ROTATABEL SNARE AND POLYP CATCHER

K-Number: K083049 · 2008-12-23

ApplicantHorizons Intl. Corp.
Decision Date2008-12-23
Product CodeFDI
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

TORNADO ROTATABEL SNARE AND POLYP CATCHER is the device name listed in this FDA 510(k) record. The listed applicant is Horizons Intl. Corp.. It received FDA 510(k) clearance on 2008-12-23 under 510(k) number K083049. 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 TORNADO ROTATABEL SNARE AND POLYP CATCHER?

TORNADO ROTATABEL SNARE AND POLYP CATCHER is a medical device that received FDA 510(k) clearance on 2008-12-23. The listed applicant is Horizons Intl. Corp.. The 510(k) number is K083049.

When did TORNADO ROTATABEL SNARE AND POLYP CATCHER receive FDA 510(k) clearance?

TORNADO ROTATABEL SNARE AND POLYP CATCHER received FDA 510(k) clearance on 2008-12-23, under 510(k) number K083049.

Who is the listed applicant for TORNADO ROTATABEL SNARE AND POLYP CATCHER?

The FDA 510(k) record lists Horizons Intl. Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TORNADO ROTATABEL SNARE AND POLYP CATCHER?

The FDA product code for TORNADO ROTATABEL SNARE AND POLYP CATCHER is FDI.

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Other records listing Horizons Intl. Corp. 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.

K022268HORIZONS REUSABLE POLYPECTOMY SNARESK022243HORIZONS REUSABLE HOT BIOPSY FORCEPSK022546HORIZONS ANSO TRANSBRONCHIAL ASPIRATION NEEDLESK021998HORIZONS CYTOLOGY BRUSHK021706HORIZONS HOT BIOPSY FORCEPSK011667HORIZONS INTERNATIONAL POLYPECTOMY SNARES

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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

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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