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FDA 510(k)

Mirus Ligating Clip, Mirus Ligating Clip Applier

K-Number: K200166 · 2020-11-23

ApplicantM/s. Meril Endo Surgery Private Limited.
Decision Date2020-11-23
Product CodeFZP
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Mirus Ligating Clip, Mirus Ligating Clip Applier 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 2020-11-23 under 510(k) number K200166. The device is classified under product code FZP. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Mirus Ligating Clip, Mirus Ligating Clip Applier?

Mirus Ligating Clip, Mirus Ligating Clip Applier is a medical device that received FDA 510(k) clearance on 2020-11-23. The listed applicant is M/s. Meril Endo Surgery Private Limited.. The 510(k) number is K200166.

When did Mirus Ligating Clip, Mirus Ligating Clip Applier receive FDA 510(k) clearance?

Mirus Ligating Clip, Mirus Ligating Clip Applier received FDA 510(k) clearance on 2020-11-23, under 510(k) number K200166.

Who is the listed applicant for Mirus Ligating Clip, Mirus Ligating Clip Applier?

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 Mirus Ligating Clip, Mirus Ligating Clip Applier?

The FDA product code for Mirus Ligating Clip, Mirus Ligating Clip Applier is FZP.

Related Clinical Trials

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NCT05363813Post-market Clinical Follow-up Study of Reusable Clip Applier Cartridge Devices for LAParoscopic SurgeryCOMPLETED

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

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Related Devices (Code: FZP)

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.

K254231Inno-Hook™ Disposable Clip Appliers (Ligating Clips) and Inno-Hook™ Ligating ClipsTaiwan Surgical CorporationK253903InnoClip Disposable Clip ApplierTaiwan Surgical CorporationK253781InnoClip Clip ApplierTaiwan Surgical CorporationK250643Disposable Polymer Ligation ClipsHangzhou Kangji Medical Instrument Co., Ltd.K251054Hem-o-lok™ PurplePlus™ Large Polymer Ligating ClipsTeleflex MedicalK242541GEM ZIPCLIPSynovis Micro Companies Alliance A Subsidiary of Baxter Int

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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