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FDA 510(k)

ETHICON NONABSORBABLE SUTURE ANCHOR

K-Number: K943950 · 1995-05-30

ApplicantETHICON, Inc.
Decision Date1995-05-30
Product CodeJDR
Advisory CommitteeOR
DecisionSubstantially Equivalent for Some Indications

Device Summary

ETHICON NONABSORBABLE SUTURE ANCHOR is the device name listed in this FDA 510(k) record. The listed applicant is ETHICON, Inc.. It received FDA 510(k) clearance on 1995-05-30 under 510(k) number K943950. The device is classified under product code JDR. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent for Some Indications.

Frequently Asked Questions

What is the ETHICON NONABSORBABLE SUTURE ANCHOR?

ETHICON NONABSORBABLE SUTURE ANCHOR is a medical device that received FDA 510(k) clearance on 1995-05-30. The listed applicant is ETHICON, Inc.. The 510(k) number is K943950.

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

ETHICON NONABSORBABLE SUTURE ANCHOR received FDA 510(k) clearance on 1995-05-30, under 510(k) number K943950.

Who is the listed applicant for ETHICON NONABSORBABLE SUTURE ANCHOR?

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

What is the FDA product code for ETHICON NONABSORBABLE SUTURE ANCHOR?

The FDA product code for ETHICON NONABSORBABLE SUTURE ANCHOR is JDR.

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Other records listing ETHICON, 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.

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Related Devices (Code: JDR)

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.

K262451Arthrex DynaNite StaplesArthrex, Inc.K261121Megalodon Dynamic Compression SystemParagon 28, Inc.K250712Linkt Compression Staple SystemTrax SurgicalK243888Medline UNITE® REFLEX® Hybrid Nitinol Implant SystemMedline Industries, LPK243742Arthrex DynaNite Nitinol StaplesArthrex, Inc.K243658TMC Compression Implant SystemTreace Medical Concepts

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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