FDA 510(k)

STERNUM SPREADER AND MITRAL VALVE RETRACTOR

K-Number: K881157 · 1988-04-06

ApplicantT. Korossurgical Instruments Corp.

Decision Date1988-04-06

Product CodeGAD

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

STERNUM SPREADER AND MITRAL VALVE RETRACTOR is the device name listed in this FDA 510(k) record. The listed applicant is T. Korossurgical Instruments Corp.. It received FDA 510(k) clearance on 1988-04-06 under 510(k) number K881157. 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 STERNUM SPREADER AND MITRAL VALVE RETRACTOR?

STERNUM SPREADER AND MITRAL VALVE RETRACTOR is a medical device that received FDA 510(k) clearance on 1988-04-06. The listed applicant is T. Korossurgical Instruments Corp.. The 510(k) number is K881157.

When did STERNUM SPREADER AND MITRAL VALVE RETRACTOR receive FDA 510(k) clearance?

STERNUM SPREADER AND MITRAL VALVE RETRACTOR received FDA 510(k) clearance on 1988-04-06, under 510(k) number K881157.

Who is the listed applicant for STERNUM SPREADER AND MITRAL VALVE RETRACTOR?

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

What is the FDA product code for STERNUM SPREADER AND MITRAL VALVE RETRACTOR?

The FDA product code for STERNUM SPREADER AND MITRAL VALVE RETRACTOR is GAD.

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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.