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FDA 510(k)

SUTURE LOCK

K-Number: K964935 · 1997-02-25

ApplicantSmith & Nephew Endoscopy, Inc.
Decision Date1997-02-25
Product CodeKGS
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

SUTURE LOCK 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 1997-02-25 under 510(k) number K964935. The device is classified under product code KGS. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SUTURE LOCK?

SUTURE LOCK is a medical device that received FDA 510(k) clearance on 1997-02-25. The listed applicant is Smith & Nephew Endoscopy, Inc.. The 510(k) number is K964935.

When did SUTURE LOCK receive FDA 510(k) clearance?

SUTURE LOCK received FDA 510(k) clearance on 1997-02-25, under 510(k) number K964935.

Who is the listed applicant for SUTURE LOCK?

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 SUTURE LOCK?

The FDA product code for SUTURE LOCK is KGS.

Related Clinical Trials

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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

View all 18 devices →

Related Devices (Code: KGS)

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.

K030031SOFT TISSUE ANCHORING WASHERSAccu-Speed, IncorporatedK020480RBMSmith & Nephew, Inc.K941740ACUFEX ROTATOR CUFF FIXATION BUTTONAcufex Microsurgical, Inc.K930675MITEK CONE WASHERMitek Surgical Products, Inc.K904435VENTROFIL TENSION RELIEF SUTURE SETAesculap, Inc.K911225TRAY DOUGHThe Hygenic Corp.

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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