| Device Type ID | 3901 |
| Device Name | Tampon, Menstrual, Unscented |
| Regulation Description | Unscented Menstrual Tampon. |
| Regulation Medical Specialty | Obstetrics/Gynecology |
| Review Panel | Obstetrics/Gynecology |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Reproductive, Gastro-Renal, And Urological Devices (DRGUD) Obstetrics And Gynecology Devices Branch (OGDB) |
| Submission Type | 510(k) |
| CFR Regulation Number | 884.5470 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | HEB |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Eligible For Accredited Persons Program |
| Device Type ID | 3901 |
| Device | Tampon, Menstrual, Unscented |
| Product Code | HEB |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Unscented Menstrual Tampon. |
| CFR Regulation Number | 884.5470 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
ALBAAD LTD. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
ALBAAD MASSUOT YITZHAK LTD. | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
COTTON HIGH TECH S.L. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
FIRST QUALITY HYGIENIC, INC. | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
KIMBERLY-CLARK | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
KIMBERLY-CLARK CORP. | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
KIMBERLY-CLARK CORPORATION | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
ONTEX NV | ||
SUBSTANTIALLY EQUIVALENT | 3 | |
THE PROCTER & GAMBLE COMPANY | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
TOSAMA D.O.O. | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
| Device Problems | |
|---|---|
Material Separation | 1728 |
Material Integrity Problem | 14 |
Adverse Event Without Identified Device Or Use Problem | 14 |
Patient-Device Incompatibility | 9 |
Difficult To Remove | 7 |
Misassembled | 5 |
Insufficient Information | 5 |
Detachment Of Device Component | 3 |
No Apparent Adverse Event | 3 |
Appropriate Term/Code Not Available | 2 |
Material Disintegration | 2 |
Torn Material | 2 |
Break | 1 |
Entrapment Of Device | 1 |
Device Damaged Prior To Use | 1 |
Manufacturing, Packaging Or Shipping Problem | 1 |
Leak / Splash | 1 |
Sticking | 1 |
Device Issue | 1 |
Material Protrusion / Extrusion | 1 |
Material Fragmentation | 1 |
Off-Label Use | 1 |
Product Quality Problem | 1 |
Defective Component | 1 |
Device Contamination With Body Fluid | 1 |
Activation, Positioning Or Separation Problem | 1 |
| Total Device Problems | 1808 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Kimberly-Clark Corporation | II | Jan-17-2019 |