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FDA 510(k)

DEGALL II GALLBLADDER EXTRACTOR

K-Number: K033359 · 2003-12-19

ApplicantSurgicon, Inc.
Decision Date2003-12-19
Product CodeGCJ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

DEGALL II GALLBLADDER EXTRACTOR is the device name listed in this FDA 510(k) record. The listed applicant is Surgicon, Inc.. It received FDA 510(k) clearance on 2003-12-19 under 510(k) number K033359. 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 DEGALL II GALLBLADDER EXTRACTOR?

DEGALL II GALLBLADDER EXTRACTOR is a medical device that received FDA 510(k) clearance on 2003-12-19. The listed applicant is Surgicon, Inc.. The 510(k) number is K033359.

When did DEGALL II GALLBLADDER EXTRACTOR receive FDA 510(k) clearance?

DEGALL II GALLBLADDER EXTRACTOR received FDA 510(k) clearance on 2003-12-19, under 510(k) number K033359.

Who is the listed applicant for DEGALL II GALLBLADDER EXTRACTOR?

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

What is the FDA product code for DEGALL II GALLBLADDER EXTRACTOR?

The FDA product code for DEGALL II GALLBLADDER EXTRACTOR is GCJ.

Related Clinical Trials

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Other records listing Surgicon, 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.

K021747DEGALL LAPAROSCOPIC GALLBLADDER EXTRACTOR

Related Devices (Code: GCJ)

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.

K262397CuratOR EX2742Eizo CorporationK260884UNIDRIVE Select SystemKarl Storz SE & CO. KGK260972OEV-271MUH LCD Monitor;OEV-321MUH LCD Monitor;OEV-431MUH LCD MonitorSony CorporationK261139VereSee (VER150, VER200, VER151, VER201, VER200C, and VER-100-103)Freyja Healthcare, LLCK253541EZ-Close™ (EZ Close Port Site Closing Device, EZ Close MAX Port Site Closing Device, EZ Close II Port Site Closing Device)Medical ImpactK261614LED LCD Monitor (OEV-271H)Lg Electronics.Inc

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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