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FDA 510(k)

AXYA MEDICAL, INC. AUTOMATIC SUTURING AND LIGATING SYSTEM-(ASLS)

K-Number: K980988 · 1998-05-11

ApplicantAxya Medical, Inc.
Decision Date1998-05-11
Product CodeGAB
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

AXYA MEDICAL, INC. AUTOMATIC SUTURING AND LIGATING SYSTEM-(ASLS) 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 1998-05-11 under 510(k) number K980988. The device is classified under product code GAB. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AXYA MEDICAL, INC. AUTOMATIC SUTURING AND LIGATING SYSTEM-(ASLS)?

AXYA MEDICAL, INC. AUTOMATIC SUTURING AND LIGATING SYSTEM-(ASLS) is a medical device that received FDA 510(k) clearance on 1998-05-11. The listed applicant is Axya Medical, Inc.. The 510(k) number is K980988.

When did AXYA MEDICAL, INC. AUTOMATIC SUTURING AND LIGATING SYSTEM-(ASLS) receive FDA 510(k) clearance?

AXYA MEDICAL, INC. AUTOMATIC SUTURING AND LIGATING SYSTEM-(ASLS) received FDA 510(k) clearance on 1998-05-11, under 510(k) number K980988.

Who is the listed applicant for AXYA MEDICAL, INC. AUTOMATIC SUTURING AND LIGATING SYSTEM-(ASLS)?

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 AXYA MEDICAL, INC. AUTOMATIC SUTURING AND LIGATING SYSTEM-(ASLS)?

The FDA product code for AXYA MEDICAL, INC. AUTOMATIC SUTURING AND LIGATING SYSTEM-(ASLS) is GAB.

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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: GAB)

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.

K012199DIGICAPHumana USA, Inc.K932591ENDO-JUDGESynergistic Medical Technologies, Inc.K895681CONTRAST BACKGROUND MATERIALApplied Medical TechnologiesK863595COATED SUTURE NEEDLESharpoint, Inc.K831648ANCHOR BRAND SURGICAL NEEDLESAnchor Products Co.K812444RADIATION STERILIZATION FOR NEEDLE CNTRDevon Industries, 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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