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FDA 510(k)

Monik™ - Disposable Endoscopic Trocar

K-Number: K233386 · 2024-05-24

ApplicantM/s. Meril Endo Surgery Private Limited.
Decision Date2024-05-24
Product CodeGCJ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Monik™ - Disposable Endoscopic Trocar is the device name listed in this FDA 510(k) record. The listed applicant is M/s. Meril Endo Surgery Private Limited.. It received FDA 510(k) clearance on 2024-05-24 under 510(k) number K233386. The device is classified under product code GCJ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Monik™ - Disposable Endoscopic Trocar?

Monik™ - Disposable Endoscopic Trocar is a medical device that received FDA 510(k) clearance on 2024-05-24. The listed applicant is M/s. Meril Endo Surgery Private Limited.. The 510(k) number is K233386.

When did Monik™ - Disposable Endoscopic Trocar receive FDA 510(k) clearance?

Monik™ - Disposable Endoscopic Trocar received FDA 510(k) clearance on 2024-05-24, under 510(k) number K233386.

Who is the listed applicant for Monik™ - Disposable Endoscopic Trocar?

The FDA 510(k) record lists M/s. Meril Endo Surgery Private Limited. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Monik™ - Disposable Endoscopic Trocar?

The FDA product code for Monik™ - Disposable Endoscopic Trocar is GCJ.

Other records listing M/s. Meril Endo Surgery Private Limited. 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.

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