Decision Date2012-08-23
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
THERMAL LIGATING SHEARS is the device name listed in this FDA 510(k) record. The listed applicant is Microline Surgical, Inc.. It received FDA 510(k) clearance on 2012-08-23 under 510(k) number K122086. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the THERMAL LIGATING SHEARS?
THERMAL LIGATING SHEARS is a medical device that received FDA 510(k) clearance on 2012-08-23. The listed applicant is Microline Surgical, Inc.. The 510(k) number is K122086.
When did THERMAL LIGATING SHEARS receive FDA 510(k) clearance?
THERMAL LIGATING SHEARS received FDA 510(k) clearance on 2012-08-23, under 510(k) number K122086.
Who is the listed applicant for THERMAL LIGATING SHEARS?
The FDA 510(k) record lists Microline Surgical, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for THERMAL LIGATING SHEARS?
The FDA product code for THERMAL LIGATING SHEARS is GEI.
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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.