FDA 510(k)

REPROCESSED ENDOSCOPIC TROCARS

K-Number: K121240 · 2012-06-11

Decision Date2012-06-11

Product CodeNLM

Advisory CommitteeGU

DecisionSubstantially Equivalent

Device Summary

REPROCESSED ENDOSCOPIC TROCARS is the device name listed in this FDA 510(k) record. The listed applicant is Sterilmed, Inc.. It received FDA 510(k) clearance on 2012-06-11 under 510(k) number K121240. The device is classified under product code NLM. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the REPROCESSED ENDOSCOPIC TROCARS?

REPROCESSED ENDOSCOPIC TROCARS is a medical device that received FDA 510(k) clearance on 2012-06-11. The listed applicant is Sterilmed, Inc.. The 510(k) number is K121240.

When did REPROCESSED ENDOSCOPIC TROCARS receive FDA 510(k) clearance?

REPROCESSED ENDOSCOPIC TROCARS received FDA 510(k) clearance on 2012-06-11, under 510(k) number K121240.

Who is the listed applicant for REPROCESSED ENDOSCOPIC TROCARS?

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

What is the FDA product code for REPROCESSED ENDOSCOPIC TROCARS?

The FDA product code for REPROCESSED ENDOSCOPIC TROCARS is NLM.

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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.