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FDA 510(k)

8 GAUGE MICROMARK II TISSUE MARKER, MODELS C1540 & C1535

K-Number: K020276 · 2002-04-12

ApplicantEthicon Endo-Surgery, Inc.
Decision Date2002-04-12
Product CodeNEU
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

8 GAUGE MICROMARK II TISSUE MARKER, MODELS C1540 & C1535 is the device name listed in this FDA 510(k) record. The listed applicant is Ethicon Endo-Surgery, Inc.. It received FDA 510(k) clearance on 2002-04-12 under 510(k) number K020276. The device is classified under product code NEU. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the 8 GAUGE MICROMARK II TISSUE MARKER, MODELS C1540 & C1535?

8 GAUGE MICROMARK II TISSUE MARKER, MODELS C1540 & C1535 is a medical device that received FDA 510(k) clearance on 2002-04-12. The listed applicant is Ethicon Endo-Surgery, Inc.. The 510(k) number is K020276.

When did 8 GAUGE MICROMARK II TISSUE MARKER, MODELS C1540 & C1535 receive FDA 510(k) clearance?

8 GAUGE MICROMARK II TISSUE MARKER, MODELS C1540 & C1535 received FDA 510(k) clearance on 2002-04-12, under 510(k) number K020276.

Who is the listed applicant for 8 GAUGE MICROMARK II TISSUE MARKER, MODELS C1540 & C1535?

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

What is the FDA product code for 8 GAUGE MICROMARK II TISSUE MARKER, MODELS C1540 & C1535?

The FDA product code for 8 GAUGE MICROMARK II TISSUE MARKER, MODELS C1540 & C1535 is NEU.

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Other records listing Ethicon Endo-Surgery, Inc. as applicant

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Related Devices (Code: NEU)

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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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