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FDA 510(k)

MERISTEEL

K-Number: K172146 · 2018-02-01

ApplicantM/s. Meril Endo Surgery Private Limited.
Decision Date2018-02-01
Product CodeGAQ
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

MERISTEEL is a medical device manufactured by M/s. Meril Endo Surgery Private Limited.. It received FDA 510(k) clearance on 2018-02-01 under approval number K172146. The device is classified under product code GAQ. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MERISTEEL?

MERISTEEL is a medical device that received FDA 510(k) clearance on 2018-02-01. It is manufactured by M/s. Meril Endo Surgery Private Limited.. The 510(k) number is K172146.

When was MERISTEEL approved by the FDA?

MERISTEEL received FDA 510(k) clearance on 2018-02-01, under approval number K172146.

What company makes MERISTEEL?

MERISTEEL is manufactured by M/s. Meril Endo Surgery Private Limited..

What is the FDA product code for MERISTEEL?

The FDA product code for MERISTEEL is GAQ.

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 K200166Mirus Ligating Clip, Mirus Ligating Clip Applier K200320Mirus Circular Stapler, Mirus Linear Cutter and Reload, Mirus Hemorrhoidal Circular Stapler, Mirus Linear Stapler and Reload K200452Meril-Bonewax

View all 11 devices →

Related Devices (Code: GAQ)

K170767Surgical Stainless Steel Suture, Stainless Steel SutureETHICON, Inc. K193209Wego-Stainless SteelFoosin Medical Supplies Inc., Ltd. K203855CoNextions TR Tendon Repair SystemConextions Medical

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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