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FDA 510(k)

PASSING NEEDLE WITH ETHIBOND, PANACRYL OR ORTHOCORD SUTURE

K-Number: K042233 · 2004-09-28

ApplicantDepuy Mitek, A Johnson & Johnson Company
Decision Date2004-09-28
Product CodeGAM
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

PASSING NEEDLE WITH ETHIBOND, PANACRYL OR ORTHOCORD SUTURE is the device name listed in this FDA 510(k) record. The listed applicant is Depuy Mitek, A Johnson & Johnson Company. It received FDA 510(k) clearance on 2004-09-28 under 510(k) number K042233. The device is classified under product code GAM. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PASSING NEEDLE WITH ETHIBOND, PANACRYL OR ORTHOCORD SUTURE?

PASSING NEEDLE WITH ETHIBOND, PANACRYL OR ORTHOCORD SUTURE is a medical device that received FDA 510(k) clearance on 2004-09-28. The listed applicant is Depuy Mitek, A Johnson & Johnson Company. The 510(k) number is K042233.

When did PASSING NEEDLE WITH ETHIBOND, PANACRYL OR ORTHOCORD SUTURE receive FDA 510(k) clearance?

PASSING NEEDLE WITH ETHIBOND, PANACRYL OR ORTHOCORD SUTURE received FDA 510(k) clearance on 2004-09-28, under 510(k) number K042233.

Who is the listed applicant for PASSING NEEDLE WITH ETHIBOND, PANACRYL OR ORTHOCORD SUTURE?

The FDA 510(k) record lists Depuy Mitek, A Johnson & Johnson Company as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PASSING NEEDLE WITH ETHIBOND, PANACRYL OR ORTHOCORD SUTURE?

The FDA product code for PASSING NEEDLE WITH ETHIBOND, PANACRYL OR ORTHOCORD SUTURE is GAM.

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Related Devices (Code: GAM)

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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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