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FDA 510(k)

ENDOPATH SURG DISP TROCAR(SHIELD/UNSHIELDED),MODIF

K-Number: K912398 · 1991-12-17

ApplicantETHICON, Inc.
Decision Date1991-12-17
Product CodeHET
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

ENDOPATH SURG DISP TROCAR(SHIELD/UNSHIELDED),MODIF is the device name listed in this FDA 510(k) record. The listed applicant is ETHICON, Inc.. It received FDA 510(k) clearance on 1991-12-17 under 510(k) number K912398. The device is classified under product code HET. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ENDOPATH SURG DISP TROCAR(SHIELD/UNSHIELDED),MODIF?

ENDOPATH SURG DISP TROCAR(SHIELD/UNSHIELDED),MODIF is a medical device that received FDA 510(k) clearance on 1991-12-17. The listed applicant is ETHICON, Inc.. The 510(k) number is K912398.

When did ENDOPATH SURG DISP TROCAR(SHIELD/UNSHIELDED),MODIF receive FDA 510(k) clearance?

ENDOPATH SURG DISP TROCAR(SHIELD/UNSHIELDED),MODIF received FDA 510(k) clearance on 1991-12-17, under 510(k) number K912398.

Who is the listed applicant for ENDOPATH SURG DISP TROCAR(SHIELD/UNSHIELDED),MODIF?

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 ENDOPATH SURG DISP TROCAR(SHIELD/UNSHIELDED),MODIF?

The FDA product code for ENDOPATH SURG DISP TROCAR(SHIELD/UNSHIELDED),MODIF is HET.

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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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