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 a medical device manufactured by M/s. Meril Endo Surgery Private Limited.. It received FDA 510(k) clearance on 2024-05-24 under approval 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. It is manufactured by M/s. Meril Endo Surgery Private Limited.. The 510(k) number is K233386.

When was Monik - Disposable Endoscopic Trocar approved by the FDA?

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

What company makes Monik - Disposable Endoscopic Trocar?

Monik - Disposable Endoscopic Trocar is manufactured by M/s. Meril Endo Surgery Private Limited..

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

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

Other Devices by M/s. Meril Endo Surgery Private Limited.

K160623FILASILK - Natural Non-absorbable Silk Surgical Suture, FILAMIDE - Non Absorbable polyamide surgical Sutures, MERICRON XL - Non Absorbable Polyester Surgical Suture, FILAPROP - Non Absorbable Polypropylene surgical Suture K172149FILASILK - Natural Non-absorbable Silk Surgical Suture, FILAMIDE - Non Absorbable polyamide surgical Sutures, MERICRON XL - Non Absorbable Polyester Surgical Suture, FILAPROP - Non Absorbable Polypropylene surgical Suture K172659MEGASORB - Natural absorbable Polyglycolic Acid Surgical Suture, MITSU - Absorbable Polyglactin 910 Surgical Sutures, MITSU FST - Absorbable Polyglactin 910 Surgical Suture, FILAXYN - Absorbable Polydioxanone Surgical (PDS), FILAPRON - Absorbable poly(glycolide-co-caprolactone) Surgical Suture K172146MERISTEEL K200166Mirus Ligating Clip, Mirus Ligating Clip Applier K200320Mirus Circular Stapler, Mirus Linear Cutter and Reload, Mirus Hemorrhoidal Circular Stapler, Mirus Linear Stapler and Reload

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Related Devices (Code: GCJ)

K163102ReliaCatch Specimen Retrieval Bag 10mm; ReliaCatch Specimen Retrieval Bag 12mmCovidien K160801Well Lead Extraction BagWell Lead Medical Co., Ltd. K153773Disposal Lens Cleaning SheathOlympus Medical Systems Corp. K161720Standard ClampStandard Bariatrics K162445LiVac Retractor SystemLivac Pty, Ltd. K162584VersaOne Bladeless TrocarCovidien

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.