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FDA 510(k)

ISI(R) HOOK SUTURE SCISSORS, MONOPOLAR

K-Number: K932697 · 1993-11-10

ApplicantInnovative Surgical, Inc.
Decision Date1993-11-10
Product CodeGCJ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

ISI(R) HOOK SUTURE SCISSORS, MONOPOLAR is the device name listed in this FDA 510(k) record. The listed applicant is Innovative Surgical, Inc.. It received FDA 510(k) clearance on 1993-11-10 under 510(k) number K932697. 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 ISI(R) HOOK SUTURE SCISSORS, MONOPOLAR?

ISI(R) HOOK SUTURE SCISSORS, MONOPOLAR is a medical device that received FDA 510(k) clearance on 1993-11-10. The listed applicant is Innovative Surgical, Inc.. The 510(k) number is K932697.

When did ISI(R) HOOK SUTURE SCISSORS, MONOPOLAR receive FDA 510(k) clearance?

ISI(R) HOOK SUTURE SCISSORS, MONOPOLAR received FDA 510(k) clearance on 1993-11-10, under 510(k) number K932697.

Who is the listed applicant for ISI(R) HOOK SUTURE SCISSORS, MONOPOLAR?

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

What is the FDA product code for ISI(R) HOOK SUTURE SCISSORS, MONOPOLAR?

The FDA product code for ISI(R) HOOK SUTURE SCISSORS, MONOPOLAR is GCJ.

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Other records listing Innovative 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.

K945394INNOVATIVE SURGICAL(R) MANGUM KNOT PUSHERK932696ISI(R) CURVED, TAPERED DISSECTING FORCEPSK932695ISI(R) PORPOISE NOSE DISSECTING FORCEPSK934075ISI METZENBAUM SCISSORSK932698ISI(R) HOOK SUTURES SCISSORSK932534ISI FENESTRATED DISSECTING AND GRASPING FORCEPS

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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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