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FDA 510(k)

SPIRAL RADIUS 90-D SST SYSTEM

K-Number: K012273 · 2001-08-15

ApplicantUnited States Surgical, A Division of Tyco Healthc
Decision Date2001-08-15
Product CodeMNH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

SPIRAL RADIUS 90-D SST SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is United States Surgical, A Division of Tyco Healthc. It received FDA 510(k) clearance on 2001-08-15 under 510(k) number K012273. The device is classified under product code MNH. It was reviewed by the OR advisory panel. Product code MNH falls under the category of ENT, which includes ear, nose, and throat diagnostic and surgical devices. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SPIRAL RADIUS 90-D SST SYSTEM?

SPIRAL RADIUS 90-D SST SYSTEM is a medical device that received FDA 510(k) clearance on 2001-08-15. The listed applicant is United States Surgical, A Division of Tyco Healthc. The 510(k) number is K012273.

When did SPIRAL RADIUS 90-D SST SYSTEM receive FDA 510(k) clearance?

SPIRAL RADIUS 90-D SST SYSTEM received FDA 510(k) clearance on 2001-08-15, under 510(k) number K012273.

Who is the listed applicant for SPIRAL RADIUS 90-D SST SYSTEM?

The FDA 510(k) record lists United States Surgical, A Division of Tyco Healthc as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SPIRAL RADIUS 90-D SST SYSTEM?

The FDA product code for SPIRAL RADIUS 90-D SST SYSTEM is MNH. This falls under the ENT category.

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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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