Gynecological Laparoscopic Kit

Device Code: 4055

Product Code(s): OHD

Definition: This Product Code Has Been Established In Accordance With The May 20, 1997, Guidance Entitled, Convenience Kits Interim Regulatory Guidance, Found At Www.Fda.Gov/cdrh/ode/convkit.Html. This Type Of Convenience Kit, As Listed In The Guidance Above, Is

Device Classification Information

Device Type ID4055
Device NameGynecological Laparoscopic Kit
Physical StateThis Product Code Has Been Established In Accordance With The May 20, 1997, Guidance Entitled, Convenience Kits Interim Regulatory Guidance, Found At Www.fda.gov/cdrh/ode/convkit.html. This Type Of Convenience Kit, As Listed In The Guidance Above, Is
Technical MethodThis Product Code Has Been Established In Accordance With The May 20, 1997, Guidance Entitled, Convenience Kits Interim Regulatory Guidance, Found At Www.fda.gov/cdrh/ode/convkit.html. This Type Of Convenience Kit, As Listed In The Guidance Above, Is
Target AreaThis Product Code Has Been Established In Accordance With The May 20, 1997, Guidance Entitled, Convenience Kits Interim Regulatory Guidance, Found At Www.fda.gov/cdrh/ode/convkit.html. This Type Of Convenience Kit, As Listed In The Guidance Above, Is
Regulation DescriptionGynecologic Laparoscope And Accessories.
Regulation Medical SpecialtyObstetrics/Gynecology
Review PanelObstetrics/Gynecology
Premarket Review Office Of Device Evaluation (ODE)
Division Of Reproductive, Gastro-Renal, And Urological Devices (DRGUD)
Obstetrics And Gynecology Devices Branch (OGDB)
Submission TypeEnforcement Discretion
CFR Regulation Number884.1720 [🔎]
FDA Device ClassificationClass 2 Medical Device
Product CodeOHD
GMP ExemptNo
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID4055
DeviceGynecological Laparoscopic Kit
Product CodeOHD
FDA Device ClassificationClass 2 Medical Device
Regulation DescriptionGynecologic Laparoscope And Accessories.
CFR Regulation Number884.1720 [🔎]
Device Problems
Adverse Event Without Identified Device Or Use Problem
4
Torn Material
3
Material Deformation
1
Material Split, Cut Or Torn
1
Total Device Problems 9
Recalls
Manufacturer Recall Class Date Posted
1
Customed, Inc
II Apr-14-2016
2
Customed, Inc
II Sep-03-2015
3
Customed, Inc
I Dec-16-2014
4
Customed, Inc
I Aug-29-2014
TPLC Last Update: 2019-04-02 20:42:18

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.