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FDA 510(k)

MICROLINE INC. REUSABLE LAPAROSCOPIC CLIP APPLIER WITH IMPLANTABLE TITANIUM CLIPS, MODEL M/L-10

K-Number: K013695 · 2002-01-08

ApplicantMicroline Pentax, Inc.
Decision Date2002-01-08
Product CodeGCJ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

MICROLINE INC. REUSABLE LAPAROSCOPIC CLIP APPLIER WITH IMPLANTABLE TITANIUM CLIPS, MODEL M/L-10 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 2002-01-08 under 510(k) number K013695. The device is classified under product code GCJ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MICROLINE INC. REUSABLE LAPAROSCOPIC CLIP APPLIER WITH IMPLANTABLE TITANIUM CLIPS, MODEL M/L-10?

MICROLINE INC. REUSABLE LAPAROSCOPIC CLIP APPLIER WITH IMPLANTABLE TITANIUM CLIPS, MODEL M/L-10 is a medical device that received FDA 510(k) clearance on 2002-01-08. The listed applicant is Microline Pentax, Inc.. The 510(k) number is K013695.

When did MICROLINE INC. REUSABLE LAPAROSCOPIC CLIP APPLIER WITH IMPLANTABLE TITANIUM CLIPS, MODEL M/L-10 receive FDA 510(k) clearance?

MICROLINE INC. REUSABLE LAPAROSCOPIC CLIP APPLIER WITH IMPLANTABLE TITANIUM CLIPS, MODEL M/L-10 received FDA 510(k) clearance on 2002-01-08, under 510(k) number K013695.

Who is the listed applicant for MICROLINE INC. REUSABLE LAPAROSCOPIC CLIP APPLIER WITH IMPLANTABLE TITANIUM CLIPS, MODEL M/L-10?

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 MICROLINE INC. REUSABLE LAPAROSCOPIC CLIP APPLIER WITH IMPLANTABLE TITANIUM CLIPS, MODEL M/L-10?

The FDA product code for MICROLINE INC. REUSABLE LAPAROSCOPIC CLIP APPLIER WITH IMPLANTABLE TITANIUM CLIPS, MODEL M/L-10 is GCJ.

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Related Devices (Code: GCJ)

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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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