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FDA 510(k)

REUSABLE, DISPOSABLE LAPAROSCOPIC INSTRUMENT AND SURGICAL DEVICE AND ACCESSORIES

K-Number: K101733 · 2011-06-06

ApplicantSac, LLC Dba Pinnacle Medical Surgical
Decision Date2011-06-06
Product CodeGCJ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

REUSABLE, DISPOSABLE LAPAROSCOPIC INSTRUMENT AND SURGICAL DEVICE AND ACCESSORIES is the device name listed in this FDA 510(k) record. The listed applicant is Sac, LLC Dba Pinnacle Medical Surgical. It received FDA 510(k) clearance on 2011-06-06 under 510(k) number K101733. 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 REUSABLE, DISPOSABLE LAPAROSCOPIC INSTRUMENT AND SURGICAL DEVICE AND ACCESSORIES?

REUSABLE, DISPOSABLE LAPAROSCOPIC INSTRUMENT AND SURGICAL DEVICE AND ACCESSORIES is a medical device that received FDA 510(k) clearance on 2011-06-06. The listed applicant is Sac, LLC Dba Pinnacle Medical Surgical. The 510(k) number is K101733.

When did REUSABLE, DISPOSABLE LAPAROSCOPIC INSTRUMENT AND SURGICAL DEVICE AND ACCESSORIES receive FDA 510(k) clearance?

REUSABLE, DISPOSABLE LAPAROSCOPIC INSTRUMENT AND SURGICAL DEVICE AND ACCESSORIES received FDA 510(k) clearance on 2011-06-06, under 510(k) number K101733.

Who is the listed applicant for REUSABLE, DISPOSABLE LAPAROSCOPIC INSTRUMENT AND SURGICAL DEVICE AND ACCESSORIES?

The FDA 510(k) record lists Sac, LLC Dba Pinnacle Medical Surgical as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for REUSABLE, DISPOSABLE LAPAROSCOPIC INSTRUMENT AND SURGICAL DEVICE AND ACCESSORIES?

The FDA product code for REUSABLE, DISPOSABLE LAPAROSCOPIC INSTRUMENT AND SURGICAL DEVICE AND ACCESSORIES is GCJ.

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Related Devices (Code: GCJ)

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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