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FDA 510(k)

SURGICAL MESH DELIVERY SYSTEM, GENERAL SURGERY

K-Number: K930147 · 1993-06-22

ApplicantDavol, Inc.
Decision Date1993-06-22
Product CodeGCJ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

SURGICAL MESH DELIVERY SYSTEM, GENERAL SURGERY is the device name listed in this FDA 510(k) record. The listed applicant is Davol, Inc.. It received FDA 510(k) clearance on 1993-06-22 under 510(k) number K930147. 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 MESH DELIVERY SYSTEM, GENERAL SURGERY?

SURGICAL MESH DELIVERY SYSTEM, GENERAL SURGERY is a medical device that received FDA 510(k) clearance on 1993-06-22. The listed applicant is Davol, Inc.. The 510(k) number is K930147.

When did SURGICAL MESH DELIVERY SYSTEM, GENERAL SURGERY receive FDA 510(k) clearance?

SURGICAL MESH DELIVERY SYSTEM, GENERAL SURGERY received FDA 510(k) clearance on 1993-06-22, under 510(k) number K930147.

Who is the listed applicant for SURGICAL MESH DELIVERY SYSTEM, GENERAL SURGERY?

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

What is the FDA product code for SURGICAL MESH DELIVERY SYSTEM, GENERAL SURGERY?

The FDA product code for SURGICAL MESH DELIVERY SYSTEM, GENERAL SURGERY is GCJ.

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Other records listing Davol, 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.

K251557Bard® Mesh; Bard® Mesh Pre-ShapedK250098Bard Soft Mesh; Bard Soft Mesh Pre-ShapedK031213AQUASENS FLUID MONITORING SYSTEMK030307DAVOL ARTHROVENT OUTFLOW TUBINGK003323COMPOSIX KUGEL MESH, MODEL 0010201,0010202,0010203,0010204,0010205K003790DAVOL X-STREAM LAPAROSCOPIC IRRIGATION SYSTEM, MODELS 5551000, 5552000, 5552001, 552002, 5552003, 5552004, 5552005

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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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