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FDA 510(k)

MRI FASTSYSTEM RETRACTOR SYSTEM

K-Number: K001339 · 2000-05-17

ApplicantOmni-Tract Surgical, Div. Minn. Scientific, Inc.
Decision Date2000-05-17
Product CodeGAD
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

MRI FASTSYSTEM RETRACTOR SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Omni-Tract Surgical, Div. Minn. Scientific, Inc.. It received FDA 510(k) clearance on 2000-05-17 under 510(k) number K001339. The device is classified under product code GAD. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MRI FASTSYSTEM RETRACTOR SYSTEM?

MRI FASTSYSTEM RETRACTOR SYSTEM is a medical device that received FDA 510(k) clearance on 2000-05-17. The listed applicant is Omni-Tract Surgical, Div. Minn. Scientific, Inc.. The 510(k) number is K001339.

When did MRI FASTSYSTEM RETRACTOR SYSTEM receive FDA 510(k) clearance?

MRI FASTSYSTEM RETRACTOR SYSTEM received FDA 510(k) clearance on 2000-05-17, under 510(k) number K001339.

Who is the listed applicant for MRI FASTSYSTEM RETRACTOR SYSTEM?

The FDA 510(k) record lists Omni-Tract Surgical, Div. Minn. Scientific, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MRI FASTSYSTEM RETRACTOR SYSTEM?

The FDA product code for MRI FASTSYSTEM RETRACTOR SYSTEM is GAD.

Related Clinical Trials

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Other records listing Omni-Tract Surgical, Div. Minn. Scientific, Inc. 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.

K992583MASS (MICRO-ACCESS SPINE SYSTEM)K950214ABDOMINAL WALL RETRACTORK913803INTRALUMINAL ARTERY STRIPPER

Related Devices (Code: GAD)

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.

K152538JRP Wound SpreaderJ.R. Parker, LLCK151104OTELO LLSpineartK132645THORATRAK MICS RETRACTOR SYSTEM, RACK, BLADESMedtronic, Inc.K071775DASHEzsurgicalK050256APPLE MEDICAL/OB MOBIUS ELASTIC RETRACTORApple Medical Corp.K043602QUADRANT RETRACTOR SYSTEMMedtronic Sofamor Danek

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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