FDA 510(k)

LITE TOUCH GELFOAM INSERT

K-Number: K862583 · 1986-07-21

Decision Date1986-07-21

Product Code

DecisionSubstantially Equivalent

Device Summary

LITE TOUCH GELFOAM INSERT is the device name listed in this FDA 510(k) record. The listed applicant is Treace Medical, Inc.. It received FDA 510(k) clearance on 1986-07-21 under 510(k) number K862583. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LITE TOUCH GELFOAM INSERT?

LITE TOUCH GELFOAM INSERT is a medical device that received FDA 510(k) clearance on 1986-07-21. The listed applicant is Treace Medical, Inc.. The 510(k) number is K862583.

When did LITE TOUCH GELFOAM INSERT receive FDA 510(k) clearance?

LITE TOUCH GELFOAM INSERT received FDA 510(k) clearance on 1986-07-21, under 510(k) number K862583.

Who is the listed applicant for LITE TOUCH GELFOAM INSERT?

The FDA 510(k) record lists Treace Medical, Inc. as the applicant. This does not by itself establish the device manufacturer.

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Other records listing Treace Medical, Inc. as applicant

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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.