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FDA 510(k)

SILS STITCH ENDOSCOPIC SUTURING DEVICE

K-Number: K090419 · 2009-03-09

ApplicantCovidien Lp, Formerly Registered AS United States
Decision Date2009-03-09
Product CodeOCW
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

SILS STITCH ENDOSCOPIC SUTURING DEVICE is the device name listed in this FDA 510(k) record. The listed applicant is Covidien Lp, Formerly Registered AS United States. It received FDA 510(k) clearance on 2009-03-09 under 510(k) number K090419. The device is classified under product code OCW. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SILS STITCH ENDOSCOPIC SUTURING DEVICE?

SILS STITCH ENDOSCOPIC SUTURING DEVICE is a medical device that received FDA 510(k) clearance on 2009-03-09. The listed applicant is Covidien Lp, Formerly Registered AS United States. The 510(k) number is K090419.

When did SILS STITCH ENDOSCOPIC SUTURING DEVICE receive FDA 510(k) clearance?

SILS STITCH ENDOSCOPIC SUTURING DEVICE received FDA 510(k) clearance on 2009-03-09, under 510(k) number K090419.

Who is the listed applicant for SILS STITCH ENDOSCOPIC SUTURING DEVICE?

The FDA 510(k) record lists Covidien Lp, Formerly Registered AS United States as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SILS STITCH ENDOSCOPIC SUTURING DEVICE?

The FDA product code for SILS STITCH ENDOSCOPIC SUTURING DEVICE is OCW.

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Other records listing Covidien Lp, Formerly Registered AS United States 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.

K091869SILS CLINCHER, SILS DISSECTOR, SILS GRASPER, SILS L-HOOK, SILS SHEARSK091900ABSORBATACK 5MM SINGLE USE ABSORBABLE FIXATION DEVICEK083519AUTOSUTURE ENDO GIA STAPLERS WITH ENDO GIA SINGLE USE LOADING UNITSK082619SILS PORT, MODELS SILSPT5, SILSPT12K082659MODIFIED ENDO STICHK081169AUTOSUTURE VERSAPORT PLUS BLADLESS TROCAR; BLADELESS TROCAR

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Related Devices (Code: OCW)

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.

K252400Endomina EZFuse systemEndo Tools Therapeutics S.A.K243750SimpleStitch Suturing SystemEnvision EndoscopyK231240MaxTack™ Motorized Fixation DeviceCovidienK213271MedicloseTM SystemHealth Value Creation B.V., Trading AS Corporis MedicalK231553OverStitch NXT Endoscopic Suturing SystemApollo Endosurgery, Inc.K211309endomina systemEndo Tools Therapeutics S.A.

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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