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FDA 510(k)

TROKAMED MORCELLATOR

K-Number: K091010 · 2011-03-01

ApplicantTrokamed GmbH
Decision Date2011-03-01
Product CodeHET
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

TROKAMED MORCELLATOR is the device name listed in this FDA 510(k) record. The listed applicant is Trokamed GmbH. It received FDA 510(k) clearance on 2011-03-01 under 510(k) number K091010. The device is classified under product code HET. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TROKAMED MORCELLATOR?

TROKAMED MORCELLATOR is a medical device that received FDA 510(k) clearance on 2011-03-01. The listed applicant is Trokamed GmbH. The 510(k) number is K091010.

When did TROKAMED MORCELLATOR receive FDA 510(k) clearance?

TROKAMED MORCELLATOR received FDA 510(k) clearance on 2011-03-01, under 510(k) number K091010.

Who is the listed applicant for TROKAMED MORCELLATOR?

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

What is the FDA product code for TROKAMED MORCELLATOR?

The FDA product code for TROKAMED MORCELLATOR is HET.

Related Clinical Trials

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Other records listing Trokamed GmbH as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K200770Mini PCNL-SystemK060233TROKAMED GMBH ENDOSCOPES AND ACCESSORIESK060232TROKAMED GMBH ELECTROSURGICAL INSTRUMENTS & ACCESSORIES

Related Devices (Code: HET)

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Official Source

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