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FDA 510(k)

SMITH & NEPHEW MIS INSTRUMENTS

K-Number: K970949 · 1997-04-23

ApplicantSmith & Nephew Endoscopy, Inc.
Decision Date1997-04-23
Product CodeGCJ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

SMITH & NEPHEW MIS INSTRUMENTS is the device name listed in this FDA 510(k) record. The listed applicant is Smith & Nephew Endoscopy, Inc.. It received FDA 510(k) clearance on 1997-04-23 under 510(k) number K970949. 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 SMITH & NEPHEW MIS INSTRUMENTS?

SMITH & NEPHEW MIS INSTRUMENTS is a medical device that received FDA 510(k) clearance on 1997-04-23. The listed applicant is Smith & Nephew Endoscopy, Inc.. The 510(k) number is K970949.

When did SMITH & NEPHEW MIS INSTRUMENTS receive FDA 510(k) clearance?

SMITH & NEPHEW MIS INSTRUMENTS received FDA 510(k) clearance on 1997-04-23, under 510(k) number K970949.

Who is the listed applicant for SMITH & NEPHEW MIS INSTRUMENTS?

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

What is the FDA product code for SMITH & NEPHEW MIS INSTRUMENTS?

The FDA product code for SMITH & NEPHEW MIS INSTRUMENTS is GCJ.

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Other records listing Smith & Nephew Endoscopy, 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.

K103309OSTEORAPTOR CURVED 2.3 SUTURE ANCHORSK102660BIORAPTOR CURVED 2.3 PK SUTURE ANCHORSK093428SMITH & NEPHEW KNOTLESS INSTABILITY ANCHORK083226SMITH & NEPHEW PEEK INTERFERENCE SCREWK083635SMITH & NEPHEW BIOSURE PK INTERFERENCE SCREWK082095ULTRASLIDE ACROMIOCLAVICULAR AND SYNDESMOTIC REPAIR DEVICE

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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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