Single-use Internal Condom

Device Code: 4013

Product Code(s): MBU

Definition: For Contraception And/or Prophylactic (preventing The Transmission Of Sexually Transmitted Infections) Purposes. At The Conclusion Of Coitus, It Is Removed And Discarded.

Device Classification Information

Device Type ID4013
Device NameSingle-use Internal Condom
Physical StateA Single-use Internal Condom Is A Sheath-like Device That Lines The Vaginal Or Anal Wall And Is Inserted Into The Vagina Or Anus Prior To The Initiation Of Coitus.
Technical MethodThe Device Is Inserted Into The Vagina Or Anus.
Target AreaVagina Or Anus
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 Type510(k)
CFR Regulation Number884.5340 [🔎]
FDA Device ClassificationClass 2 Medical Device
Product CodeMBU
GMP ExemptNo
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID4013
DeviceSingle-use Internal Condom
Product CodeMBU
FDA Device ClassificationClass 2 Medical Device
CFR Regulation Number884.5340 [🔎]
TPLC Last Update: 2019-04-02 20:41:39

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