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FDA 510(k)

CHRISTOUDIAS GAUZE DISSECTOR (LAPAROSCOPIC HAND INSTRUMENT)

K-Number: K982428 · 1998-10-09

ApplicantInnervision, Inc.
Decision Date1998-10-09
Product CodeHET
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

CHRISTOUDIAS GAUZE DISSECTOR (LAPAROSCOPIC HAND INSTRUMENT) is the device name listed in this FDA 510(k) record. The listed applicant is Innervision, Inc.. It received FDA 510(k) clearance on 1998-10-09 under 510(k) number K982428. 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 CHRISTOUDIAS GAUZE DISSECTOR (LAPAROSCOPIC HAND INSTRUMENT)?

CHRISTOUDIAS GAUZE DISSECTOR (LAPAROSCOPIC HAND INSTRUMENT) is a medical device that received FDA 510(k) clearance on 1998-10-09. The listed applicant is Innervision, Inc.. The 510(k) number is K982428.

When did CHRISTOUDIAS GAUZE DISSECTOR (LAPAROSCOPIC HAND INSTRUMENT) receive FDA 510(k) clearance?

CHRISTOUDIAS GAUZE DISSECTOR (LAPAROSCOPIC HAND INSTRUMENT) received FDA 510(k) clearance on 1998-10-09, under 510(k) number K982428.

Who is the listed applicant for CHRISTOUDIAS GAUZE DISSECTOR (LAPAROSCOPIC HAND INSTRUMENT)?

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

What is the FDA product code for CHRISTOUDIAS GAUZE DISSECTOR (LAPAROSCOPIC HAND INSTRUMENT)?

The FDA product code for CHRISTOUDIAS GAUZE DISSECTOR (LAPAROSCOPIC HAND INSTRUMENT) is HET.

Related Clinical Trials

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Other records listing Innervision, 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.

K992345CHRISTOUDIAS SLIM TIP ELECTRODE INSERTK991877MACMED PAEDIATRIC INTRAMEDULLARY NAILK940731INNERVISION INC. CANNULA/TROCAR,MULTIPLE TYPESK940750INNERVISION,INC. LAPAROSCOPIC ELECTRODESK940718INNERVISION INC. LAPAROSCOPIC HAND INSTRUMENTS

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Official Source

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