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FDA 510(k)

SMITH & NEPHEW SUTURE LOK

K-Number: K991500 · 1999-07-14

ApplicantSmith & Nephew Endoscopy, Inc.
Decision Date1999-07-14
Product CodeOCW
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

SMITH & NEPHEW SUTURE LOK is the device name listed in this FDA 510(k) record. The listed applicant is Smith & Nephew Endoscopy, Inc.. It received FDA 510(k) clearance on 1999-07-14 under 510(k) number K991500. 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 SMITH & NEPHEW SUTURE LOK?

SMITH & NEPHEW SUTURE LOK is a medical device that received FDA 510(k) clearance on 1999-07-14. The listed applicant is Smith & Nephew Endoscopy, Inc.. The 510(k) number is K991500.

When did SMITH & NEPHEW SUTURE LOK receive FDA 510(k) clearance?

SMITH & NEPHEW SUTURE LOK received FDA 510(k) clearance on 1999-07-14, under 510(k) number K991500.

Who is the listed applicant for SMITH & NEPHEW SUTURE LOK?

The FDA 510(k) record lists Smith & Nephew Endoscopy, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SMITH & NEPHEW SUTURE LOK?

The FDA product code for SMITH & NEPHEW SUTURE LOK is OCW.

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Other records listing Smith & Nephew Endoscopy, Inc. 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.

K103309OSTEORAPTOR CURVED 2.3 SUTURE ANCHORSK102660BIORAPTOR CURVED 2.3 PK SUTURE ANCHORSK093428SMITH & NEPHEW KNOTLESS INSTABILITY ANCHORK083226SMITH & NEPHEW PEEK INTERFERENCE SCREWK083635SMITH & NEPHEW BIOSURE PK INTERFERENCE SCREWK082095ULTRASLIDE ACROMIOCLAVICULAR AND SYNDESMOTIC REPAIR DEVICE

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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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