Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

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 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 2018-02-01 under 510(k) 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. The listed applicant is M/s. Meril Endo Surgery Private Limited.. The 510(k) number is K172146.

When did MERISTEEL receive FDA 510(k) clearance?

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

Who is the listed applicant for MERISTEEL?

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 MERISTEEL?

The FDA product code for MERISTEEL is GAQ.

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

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.

K252644PINION™ PDO Knotless Suture - Absorbable Poly (P-Dioxanone) Knotless Suture; PINION™ PGA-PCL Knotless Suture - Absorbable Poly (Glycolide-Co-Caprolactone) Knotless SutureK233386Monik™ - Disposable Endoscopic TrocarK2322461) PINION™ PDO Knotless Suture - Absorbable Poly (P-Dioxanone) Knotless Suture; 2) PINION™ PGA-PCL Knotless Suture - Absorbable Polyglycolic Acid - Poly (Glycolide-Co-Caprolactone) Knotless SutureK230981Meriglu Topical Skin AdhesiveK200452Meril-BonewaxK200320Mirus Circular Stapler, Mirus Linear Cutter and Reload, Mirus Hemorrhoidal Circular Stapler, Mirus Linear Stapler and Reload

View all 11 devices →

Related Devices (Code: GAQ)

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.

K203855CoNextions TR Tendon Repair SystemConextions MedicalK193209Wego-Stainless SteelFoosin Medical Supplies Inc., Ltd.K170767Surgical Stainless Steel Suture, Stainless Steel SutureETHICON, Inc.

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.

↑