FDA 510(k)

RETRACTORS, SPECULUM, CLIP APPLIER FOR TITANIUM CLIPS, 2-WAY STOP COCK, PALPATION PROBE, KNOT GUIDE, ROEDER LOOP

K-Number: K936250 · 1994-05-12

Decision Date1994-05-12

Product CodeGCJ

Advisory CommitteeGU

DecisionSubstantially Equivalent

Device Summary

RETRACTORS, SPECULUM, CLIP APPLIER FOR TITANIUM CLIPS, 2-WAY STOP COCK, PALPATION PROBE, KNOT GUIDE, ROEDER LOOP is the device name listed in this FDA 510(k) record. The listed applicant is Medicon Instruments, Inc.. It received FDA 510(k) clearance on 1994-05-12 under 510(k) number K936250. 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 RETRACTORS, SPECULUM, CLIP APPLIER FOR TITANIUM CLIPS, 2-WAY STOP COCK, PALPATION PROBE, KNOT GUIDE, ROEDER LOOP?

RETRACTORS, SPECULUM, CLIP APPLIER FOR TITANIUM CLIPS, 2-WAY STOP COCK, PALPATION PROBE, KNOT GUIDE, ROEDER LOOP is a medical device that received FDA 510(k) clearance on 1994-05-12. The listed applicant is Medicon Instruments, Inc.. The 510(k) number is K936250.

When did RETRACTORS, SPECULUM, CLIP APPLIER FOR TITANIUM CLIPS, 2-WAY STOP COCK, PALPATION PROBE, KNOT GUIDE, ROEDER LOOP receive FDA 510(k) clearance?

RETRACTORS, SPECULUM, CLIP APPLIER FOR TITANIUM CLIPS, 2-WAY STOP COCK, PALPATION PROBE, KNOT GUIDE, ROEDER LOOP received FDA 510(k) clearance on 1994-05-12, under 510(k) number K936250.

Who is the listed applicant for RETRACTORS, SPECULUM, CLIP APPLIER FOR TITANIUM CLIPS, 2-WAY STOP COCK, PALPATION PROBE, KNOT GUIDE, ROEDER LOOP?

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

What is the FDA product code for RETRACTORS, SPECULUM, CLIP APPLIER FOR TITANIUM CLIPS, 2-WAY STOP COCK, PALPATION PROBE, KNOT GUIDE, ROEDER LOOP?

The FDA product code for RETRACTORS, SPECULUM, CLIP APPLIER FOR TITANIUM CLIPS, 2-WAY STOP COCK, PALPATION PROBE, KNOT GUIDE, ROEDER LOOP is GCJ.

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Other records listing Medicon Instruments, Inc. as applicant

K936249MEDICON INSTRUMENTS UNIPOLAR COAGULATION ELECTRODES K936246MEDICON INSTRUMENTS BIPOLAR FORCEPTS AND ELECTRODES K936262DISSECTORS, FORCEPS, SCISSORS, DILATION SETS, AND GALL STONE COLLECTORS K936247MEDICON INSTRUMENTS TROCARS, TROCAR SLEEVES AND REDUCTION SLEEVES K936248MEDICON INSTRUMENTS CHOLANGIOGRAPHY NEEDLES, GUIDE TUBES, INJECTION NEEDLES, VERRES INSUFFLATION NEEDLES AND HOLDERS

Related Devices (Code: GCJ)

K262397CuratOR EX2742Eizo Corporation K260884UNIDRIVE Select SystemKarl Storz SE & CO. KG K260972OEV-271MUH LCD Monitor;OEV-321MUH LCD Monitor;OEV-431MUH LCD MonitorSony Corporation K261139VereSee (VER150, VER200, VER151, VER201, VER200C, and VER-100-103)Freyja Healthcare, LLC K253541EZ-Close™ (EZ Close Port Site Closing Device, EZ Close MAX Port Site Closing Device, EZ Close II Port Site Closing Device)Medical Impact K261614LED 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.