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FDA 510(k)

UNITROCAR(TM) REUSABLE SURG TROCAR/RESUSE KIT

K-Number: K926341 · 1993-05-17

ApplicantUnisurge, Inc.
Decision Date1993-05-17
Product CodeGCJ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

UNITROCAR(TM) REUSABLE SURG TROCAR/RESUSE KIT is the device name listed in this FDA 510(k) record. The listed applicant is Unisurge, Inc.. It received FDA 510(k) clearance on 1993-05-17 under 510(k) number K926341. 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 UNITROCAR(TM) REUSABLE SURG TROCAR/RESUSE KIT?

UNITROCAR(TM) REUSABLE SURG TROCAR/RESUSE KIT is a medical device that received FDA 510(k) clearance on 1993-05-17. The listed applicant is Unisurge, Inc.. The 510(k) number is K926341.

When did UNITROCAR(TM) REUSABLE SURG TROCAR/RESUSE KIT receive FDA 510(k) clearance?

UNITROCAR(TM) REUSABLE SURG TROCAR/RESUSE KIT received FDA 510(k) clearance on 1993-05-17, under 510(k) number K926341.

Who is the listed applicant for UNITROCAR(TM) REUSABLE SURG TROCAR/RESUSE KIT?

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

What is the FDA product code for UNITROCAR(TM) REUSABLE SURG TROCAR/RESUSE KIT?

The FDA product code for UNITROCAR(TM) REUSABLE SURG TROCAR/RESUSE KIT is GCJ.

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Other records listing Unisurge, 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.

K943502UNIGRIPK933720INSTRUMENT ACTUATING DEVICE (IAD)K930605APPLIER, SURGICAL, CLIPK930617OBGRIP AND UNITIPS(TM)K925917UNICHANNEL(TM SURGICAL GRASPERK932604UNIGRIP-FH SURGICAL HANDPIECE/LAPAROSCOPIC

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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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