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FDA 510(k)

SURGICAL RETRACTOR KIT

K-Number: K940193 · 1994-02-15

ApplicantAdvanced Surgical, Inc.
Decision Date1994-02-15
Product CodeGCJ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

SURGICAL RETRACTOR KIT is the device name listed in this FDA 510(k) record. The listed applicant is Advanced Surgical, Inc.. It received FDA 510(k) clearance on 1994-02-15 under 510(k) number K940193. 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 SURGICAL RETRACTOR KIT?

SURGICAL RETRACTOR KIT is a medical device that received FDA 510(k) clearance on 1994-02-15. The listed applicant is Advanced Surgical, Inc.. The 510(k) number is K940193.

When did SURGICAL RETRACTOR KIT receive FDA 510(k) clearance?

SURGICAL RETRACTOR KIT received FDA 510(k) clearance on 1994-02-15, under 510(k) number K940193.

Who is the listed applicant for SURGICAL RETRACTOR KIT?

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

What is the FDA product code for SURGICAL RETRACTOR KIT?

The FDA product code for SURGICAL RETRACTOR KIT is GCJ.

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Other records listing Advanced Surgical, 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.

K950126ENDOSCOPIC LIGATION DEVICE, LIGATOR HANDLE, LIGATOR CARTRIDGEK950005TROCAR CANNULA STABILIZERK945369LAPAROSCOPIC SURGICAL INSTRUMENTS FOR GENERAL USEK933497LAPAROSCOPIC COVERED SURGICAL RETRACTORK941500TISSUE ISOLATION AND RETRIEVAL BAGK931850VERRSS PNEUMO NEEDLE

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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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