FDA 510(k)

ACCUSHEAR LAPAROSCOPIC SURGICAL INSTRUMENTS

K-Number: K982984 · 1998-10-21

Decision Date1998-10-21

Product CodeGEI

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

ACCUSHEAR LAPAROSCOPIC SURGICAL INSTRUMENTS is the device name listed in this FDA 510(k) record. The listed applicant is Microline Pentax, Inc.. It received FDA 510(k) clearance on 1998-10-21 under 510(k) number K982984. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ACCUSHEAR LAPAROSCOPIC SURGICAL INSTRUMENTS?

ACCUSHEAR LAPAROSCOPIC SURGICAL INSTRUMENTS is a medical device that received FDA 510(k) clearance on 1998-10-21. The listed applicant is Microline Pentax, Inc.. The 510(k) number is K982984.

When did ACCUSHEAR LAPAROSCOPIC SURGICAL INSTRUMENTS receive FDA 510(k) clearance?

ACCUSHEAR LAPAROSCOPIC SURGICAL INSTRUMENTS received FDA 510(k) clearance on 1998-10-21, under 510(k) number K982984.

Who is the listed applicant for ACCUSHEAR LAPAROSCOPIC SURGICAL INSTRUMENTS?

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

What is the FDA product code for ACCUSHEAR LAPAROSCOPIC SURGICAL INSTRUMENTS?

The FDA product code for ACCUSHEAR LAPAROSCOPIC SURGICAL INSTRUMENTS is GEI.

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Other records listing Microline Pentax, Inc. as applicant

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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.