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FDA 510(k)

SUTURE WELDING SYSTEM AND KIT (SWK)

K-Number: K983108 · 1998-11-27

ApplicantAxya Medical, Inc.
Decision Date1998-11-27
Product CodeGAW
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

SUTURE WELDING SYSTEM AND KIT (SWK) is the device name listed in this FDA 510(k) record. The listed applicant is Axya Medical, Inc.. It received FDA 510(k) clearance on 1998-11-27 under 510(k) number K983108. The device is classified under product code GAW. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SUTURE WELDING SYSTEM AND KIT (SWK)?

SUTURE WELDING SYSTEM AND KIT (SWK) is a medical device that received FDA 510(k) clearance on 1998-11-27. The listed applicant is Axya Medical, Inc.. The 510(k) number is K983108.

When did SUTURE WELDING SYSTEM AND KIT (SWK) receive FDA 510(k) clearance?

SUTURE WELDING SYSTEM AND KIT (SWK) received FDA 510(k) clearance on 1998-11-27, under 510(k) number K983108.

Who is the listed applicant for SUTURE WELDING SYSTEM AND KIT (SWK)?

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

What is the FDA product code for SUTURE WELDING SYSTEM AND KIT (SWK)?

The FDA product code for SUTURE WELDING SYSTEM AND KIT (SWK) is GAW.

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Other records listing Axya Medical, 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.

K070773AXYA, MODEL 3000 AXYZLOOP TITANIUM BONE ANCHORK070253AXYA SUTURE WELDING SYSTEM AND KITK063194TUFFLEX POLYESTER SUTUREK060165AXYAFLEX POLYESTER SUTUREK060970AXYALOOP NONABSORBABLE BONE ANCHORK052491AXYA MODEL 6500 AXYALOOP SELF-TAPPING BONE ANCHOR

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Related Devices (Code: GAW)

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.

K253572STRATAFIX™ Spiral PRONOVA™ Unidirectional Knotless Tissue Control Device STRATAFIX™ Spiral PRONOVA™ Bidirectional Knotless Tissue Control DeviceETHICON, Inc.K233355Cypris eXact Suturing SystemCypris MedicalK230746Non absorbable Surgical Polypropylene SutureShandong Haidike Medical Products Co., Ltd.K221280VessealLydus Medical , Ltd.K211178DURAMESH Mesh SutureMsiK192953APTOS Threads – Polypropylene Surgical SuturesAptos, LLC

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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