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FDA 510(k)

DISPOSABLE TROCAR SLEEVE WITH DILATING OBTURATOR

K-Number: K914968 · 1992-02-03

ApplicantETHICON, Inc.
Decision Date1992-02-03
Product CodeHET
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

DISPOSABLE TROCAR SLEEVE WITH DILATING OBTURATOR is the device name listed in this FDA 510(k) record. The listed applicant is ETHICON, Inc.. It received FDA 510(k) clearance on 1992-02-03 under 510(k) number K914968. 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 DISPOSABLE TROCAR SLEEVE WITH DILATING OBTURATOR?

DISPOSABLE TROCAR SLEEVE WITH DILATING OBTURATOR is a medical device that received FDA 510(k) clearance on 1992-02-03. The listed applicant is ETHICON, Inc.. The 510(k) number is K914968.

When did DISPOSABLE TROCAR SLEEVE WITH DILATING OBTURATOR receive FDA 510(k) clearance?

DISPOSABLE TROCAR SLEEVE WITH DILATING OBTURATOR received FDA 510(k) clearance on 1992-02-03, under 510(k) number K914968.

Who is the listed applicant for DISPOSABLE TROCAR SLEEVE WITH DILATING OBTURATOR?

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 DISPOSABLE TROCAR SLEEVE WITH DILATING OBTURATOR?

The FDA product code for DISPOSABLE TROCAR SLEEVE WITH DILATING OBTURATOR 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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