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FDA 510(k)

ACUMED SUTURE ANCHOR

K-Number: K980103 · 1998-03-16

ApplicantAcu Med, Inc.
Decision Date1998-03-16
Product CodeMBI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

ACUMED SUTURE ANCHOR is the device name listed in this FDA 510(k) record. The listed applicant is Acu Med, Inc.. It received FDA 510(k) clearance on 1998-03-16 under 510(k) number K980103. The device is classified under product code MBI. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ACUMED SUTURE ANCHOR?

ACUMED SUTURE ANCHOR is a medical device that received FDA 510(k) clearance on 1998-03-16. The listed applicant is Acu Med, Inc.. The 510(k) number is K980103.

When did ACUMED SUTURE ANCHOR receive FDA 510(k) clearance?

ACUMED SUTURE ANCHOR received FDA 510(k) clearance on 1998-03-16, under 510(k) number K980103.

Who is the listed applicant for ACUMED SUTURE ANCHOR?

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

What is the FDA product code for ACUMED SUTURE ANCHOR?

The FDA product code for ACUMED SUTURE ANCHOR is MBI.

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Other records listing Acu Med, 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.

K021321WRIST FUSION PLATEK013616POLARUS CAP SCREWK012655CONGRUENT BONE PLATE SYSTEMK992525ACUMED MODULAR SHOULDER SYSTEMK993657ACUMED SUTURE ANCHORK965028ACUMED SUTURE WASHER

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Related Devices (Code: MBI)

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.

K261869Integrity Retractable Implant Inserter (6000127)Anika Therapeutics, Inc.K262809ArthroTAK Tendon Anchor KitArthroTAK, LLCK253065Aevumed SUPERCYNCH™ Button SystemAevumed, Inc.K262677Iconix Knotless TRiverpoint MedicalK262047Grappler Suture Anchor SystemParagon 28, Inc.K262369AIR+ All-Inside Meniscal Repair Device, Curved Up;AIR+ All-Inside Meniscal Repair Device, Curved DownStryker Endoscopy

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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