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FDA 510(k)

OPTIK LAPAROSCOPE

K-Number: K933776 · 1994-03-16

ApplicantOptik
Decision Date1994-03-16
Product CodeGCJ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

OPTIK LAPAROSCOPE is the device name listed in this FDA 510(k) record. The listed applicant is Optik. It received FDA 510(k) clearance on 1994-03-16 under 510(k) number K933776. 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 OPTIK LAPAROSCOPE?

OPTIK LAPAROSCOPE is a medical device that received FDA 510(k) clearance on 1994-03-16. The listed applicant is Optik. The 510(k) number is K933776.

When did OPTIK LAPAROSCOPE receive FDA 510(k) clearance?

OPTIK LAPAROSCOPE received FDA 510(k) clearance on 1994-03-16, under 510(k) number K933776.

Who is the listed applicant for OPTIK LAPAROSCOPE?

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

What is the FDA product code for OPTIK LAPAROSCOPE?

The FDA product code for OPTIK LAPAROSCOPE is GCJ.

Related Clinical Trials

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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Other records listing Optik 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.

K926166COAST VIDEO ENDOSCOPIC IMAGING SYSTEMK896404TITAMED ANTWERP SYSTEMK896589MANUAL SURGICAL INSTRUMENTS FOR TITAMED ANTWERPK894558MINI LIGHTSCOPE SET, LIGHTSCOPE JR. SETK894557LIGHTSCOPE SET

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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