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FDA 510(k)

SUTURE TENSION ADJUSTMENT REEL

K-Number: K904136 · 1990-10-02

ApplicantSurgical Systems, Inc.
Decision Date1990-10-02
Product CodeKGS
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

SUTURE TENSION ADJUSTMENT REEL is the device name listed in this FDA 510(k) record. The listed applicant is Surgical Systems, Inc.. It received FDA 510(k) clearance on 1990-10-02 under 510(k) number K904136. 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 TENSION ADJUSTMENT REEL?

SUTURE TENSION ADJUSTMENT REEL is a medical device that received FDA 510(k) clearance on 1990-10-02. The listed applicant is Surgical Systems, Inc.. The 510(k) number is K904136.

When did SUTURE TENSION ADJUSTMENT REEL receive FDA 510(k) clearance?

SUTURE TENSION ADJUSTMENT REEL received FDA 510(k) clearance on 1990-10-02, under 510(k) number K904136.

Who is the listed applicant for SUTURE TENSION ADJUSTMENT REEL?

The FDA 510(k) record lists Surgical Systems, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SUTURE TENSION ADJUSTMENT REEL?

The FDA product code for SUTURE TENSION ADJUSTMENT REEL 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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Surgical Systems, 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.

K802868ACCU-COUNTER SURGICAL SPONGE COUNTING SY

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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