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FDA 510(k)

SUTURE RETENTION DEVICE

K-Number: K883299 · 1988-08-23

ApplicantEdwards Orthopaedics Div., Baxter Healthcare Corp.
Decision Date1988-08-23
Product CodeKGS
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

SUTURE RETENTION DEVICE is the device name listed in this FDA 510(k) record. The listed applicant is Edwards Orthopaedics Div., Baxter Healthcare Corp.. It received FDA 510(k) clearance on 1988-08-23 under 510(k) number K883299. 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 RETENTION DEVICE?

SUTURE RETENTION DEVICE is a medical device that received FDA 510(k) clearance on 1988-08-23. The listed applicant is Edwards Orthopaedics Div., Baxter Healthcare Corp.. The 510(k) number is K883299.

When did SUTURE RETENTION DEVICE receive FDA 510(k) clearance?

SUTURE RETENTION DEVICE received FDA 510(k) clearance on 1988-08-23, under 510(k) number K883299.

Who is the listed applicant for SUTURE RETENTION DEVICE?

The FDA 510(k) record lists Edwards Orthopaedics Div., Baxter Healthcare Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SUTURE RETENTION DEVICE?

The FDA product code for SUTURE RETENTION DEVICE is KGS.

Related Clinical Trials

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.

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Other records listing Edwards Orthopaedics Div., Baxter Healthcare Corp. 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.

K883300IRRIGATION SET

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.K964935SUTURE LOCKSmith & Nephew Endoscopy, Inc.K941740ACUFEX ROTATOR CUFF FIXATION BUTTONAcufex Microsurgical, Inc.K930675MITEK CONE WASHERMitek Surgical Products, Inc.K904435VENTROFIL TENSION RELIEF SUTURE SETAesculap, 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.

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