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M/s. Meril Endo Surgery Private Limited.

US

Last updated May 23, 2026

What M/s. Meril Endo Surgery Private Limited. makes

The company manufactures surgical sutures, including absorbable options like PDO, PGA-PCL, polyglactin 910, and polydioxanone, as well as non-absorbable variants such as silk, polyamide, polyester, and polypropylene. It also produces surgical staplers—linear, circular, and hemorrhoidal—and trocars for endoscopic procedures. Topical skin adhesives and ligating clips with applicators for surgical applications are part of the portfolio.

The portfolio includes Class II and Unclassified (U) devices, with submissions recorded in the FDA’s 510(k) registry. The manufacturer is based in the United States.

Written from this company's registered devices by an AI model, and not verified by a human reviewer.

Frequently asked questions

What types of medical devices does M/s. Meril Endo Surgery Private Limited manufacture?

M/s. Meril Endo Surgery Private Limited manufactures a range of surgical devices, including absorbable and non-absorbable sutures (such as PDO, PGA-PCL, polyglactin 910, silk, polyamide, polyester, and polypropylene), surgical staplers (linear, circular, and hemorrhoidal), endoscopic trocars, ligating clips with applicators, and topical skin adhesives. These devices are designed for various surgical applications, including tissue closure, wound repair, and endoscopic procedures.

Where is M/s. Meril Endo Surgery Private Limited based?

The company is based in the United States, as indicated in its regulatory documentation. This location is relevant for understanding its operational and compliance context, particularly for regulatory submissions and device authorisation processes.

Which regulatory registries list the devices manufactured by M/s. Meril Endo Surgery Private Limited?

The company’s devices are recorded in the FDA’s 510(k) registry, which is a database of premarket notifications submitted for Class II devices in the United States. This registry tracks submissions for devices seeking clearance under the FDA’s 510(k) process, ensuring transparency about their regulatory status.

How are the devices manufactured by M/s. Meril Endo Surgery Private Limited classified?

The devices produced by the company fall under Class II and Unclassified (U) categories in the regulatory framework. Class II devices typically require special controls to ensure their safety and effectiveness, while Unclassified devices may undergo a different evaluation process depending on their risk profile. The classification determines the regulatory pathway for authorisation.

What distinguishes the sutures offered by M/s. Meril Endo Surgery Private Limited from other surgical sutures?

The company’s suture portfolio includes both absorbable (e.g., PDO, PGA-PCL, polyglactin 910) and non-absorbable (e.g., silk, polyamide, polyester) options, each tailored for specific surgical needs. Absorbable sutures dissolve over time, reducing the need for removal, while non-absorbable sutures provide long-term support. The inclusion of knotless designs (like PINION PDO and PGA-PCL) also simplifies handling during procedures, potentially improving efficiency for surgeons.

AI-generated from registry data and not verified by a human reviewer.

Information

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US
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Catalogue (499)

Page 2 of 10
DeviceModel / ReferenceRegistriesClassStatus
Megasorb PGA20843UZ
FDA UDI
Class IIActive
Filaxyn PDX50126DNZ
FDA UDI
Class IIActive
Megasorb PGA20823UZ
FDA UDI
Class IIActive
Filaprop PPL308663
FDA UDI
Class IIActive
Mitsu PGN80401
FDA UDI
Class IIActive
Filamide NYL20585Z
FDA UDI
Class IIActive
Mitsu PGN10267UZ
FDA UDI
Class IIActive
Mitsu PGNS30285U
FDA UDI
Class IIActive
Mitsu PGN80975DN
FDA UDI
Class IIActive
Filaprop PPL908229DN
FDA UDI
Class IIActive
Filapron PCL40935UZ
FDA UDI
Class IIActive
Megasorb MS2534
FDA UDI
Class IIActive
Filaxyn PDX50463
FDA UDI
Class IIActive
Ppl506870dnz PPL506870DNZ
FDA UDI
Class IIActive
Filaprop PPL901754DN
FDA UDI
Class IIActive
Mitsu PGN20417UZ
FDA UDI
Class IIActive
Filamide NYL501955
FDA UDI
Class IIActive
Mitsu PGN10603Z
FDA UDI
Class IIActive
Filaprop PPL208843DNZ
FDA UDI
Class IIActive
Filaxyn PDX40304Z
FDA UDI
Class IIActive
Filaprop PPL100788DN
FDA UDI
Class IIActive
Filaprop PPL608706DNZ
FDA UDI
Class IIActive
Megasorb PGA01905Z
FDA UDI
Class IIActive
Filaxyn PDX60127DNZ
FDA UDI
Class IIActive
Filapron PCL50834U
FDA UDI
Class IIActive
Filasilk SLK201588Z
FDA UDI
Class IIActive
Filaprop PPL408699
FDA UDI
Class IIActive
Filaprop PPL1009091DN
FDA UDI
Class IIActive
Megasorb PGA20953UZ
FDA UDI
Class IIActive
Filaxyn PDX40513
FDA UDI
Class IIActive
Filamide NYL40699Z
FDA UDI
Class IIActive
Megasorb PGA30693UZ
FDA UDI
Class IIActive
Mitsu PGN50506U
FDA UDI
Class IIActive
Filamide NYL20664
FDA UDI
Class IIActive
Filaprop PPL508890Z
FDA UDI
Class IIActive
Filaprop PPL408682
FDA UDI
Class IIActive
Filamide NYL40699
FDA UDI
Class IIActive
Filaprop PPL608697
FDA UDI
Class IIActive
Filapron PCL30427UZ
FDA UDI
Class IIActive
Megasorb MS200466
FDA UDI
Class IIActive
Megasorb MS2518
FDA UDI
Class IIActive
Filaprop PPL50556Z
FDA UDI
Class IIActive
Filapron PCL10358VZ
FDA UDI
Class IIActive
Mitsu PGN02195UZ
FDA UDI
Class IIActive
Filaprop PPL60709Z
FDA UDI
Class IIActive
Filaprop PPL20411Z
FDA UDI
Class IIActive
Filamide NYL900112
FDA UDI
Class IIActive
Mitsu PGN109420
FDA UDI
Class IIActive
Filaprop PPL70713Z
FDA UDI
Class IIActive
Filaprop PPL608610DNZ
FDA UDI
Class IIActive

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