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FDA 510(k)

ENDOSCOPIC CAMERA

K-Number: K991416 · 1999-07-20

ApplicantGenzyme Surgical Product (Genzyme Biosurgery)
Decision Date1999-07-20
Product CodeGCJ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

ENDOSCOPIC CAMERA is the device name listed in this FDA 510(k) record. The listed applicant is Genzyme Surgical Product (Genzyme Biosurgery). It received FDA 510(k) clearance on 1999-07-20 under 510(k) number K991416. 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 ENDOSCOPIC CAMERA?

ENDOSCOPIC CAMERA is a medical device that received FDA 510(k) clearance on 1999-07-20. The listed applicant is Genzyme Surgical Product (Genzyme Biosurgery). The 510(k) number is K991416.

When did ENDOSCOPIC CAMERA receive FDA 510(k) clearance?

ENDOSCOPIC CAMERA received FDA 510(k) clearance on 1999-07-20, under 510(k) number K991416.

Who is the listed applicant for ENDOSCOPIC CAMERA?

The FDA 510(k) record lists Genzyme Surgical Product (Genzyme Biosurgery) as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ENDOSCOPIC CAMERA?

The FDA product code for ENDOSCOPIC CAMERA is GCJ.

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Other records listing Genzyme Surgical Product (Genzyme Biosurgery) 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.

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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

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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