Definition: Used To Aid In Insertion, Placement, Fixation, Or Anchoring Of Surgical Mesh For Stress Urinary Incontinence
Device Type ID | 2167 |
Device Name | Instrumentation, Surgical Mesh, Urogynecologic, Stress Urinary Incontinence |
Physical State | Needle Passers And Trocars, Needle Guides, Fixation Tools, And Tissue Anchors Used With Surgical Mesh. |
Technical Method | Used With Urogynecologic Surgical Mesh Instrumentation To Facilitate Stress Urinary Incontinence Procedures |
Target Area | Urethra, Vagina, Pelvic Floor |
Regulation Description | Specialized Surgical Instrumentation For Use With Urogynecologic Surgical Mesh. |
Regulation Medical Specialty | Obstetrics/Gynecology |
Review Panel | Gastroenterology/Urology |
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 | 884.4910 [🔎] |
FDA Device Classification | Class 2 Medical Device |
Product Code | PWJ |
GMP Exempt | No |
Summary MR | Ineligible |
Implanted Device | No |
Life Support Device | No |
Third Party Review | Not Third Party Eligible |
Device Type ID | 2167 |
Device | Instrumentation, Surgical Mesh, Urogynecologic, Stress Urinary Incontinence |
Product Code | PWJ |
FDA Device Classification | Class 2 Medical Device |
Regulation Description | Specialized Surgical Instrumentation For Use With Urogynecologic Surgical Mesh. |
CFR Regulation Number | 884.4910 [🔎] |
Premarket Reviews | ||
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Manufacturer | Decision | |
BOSTON SCIENTIFIC CORP. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
BOSTON SCIENTIFIC CORPORATION | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
CALDERA MEDICAL | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
CALDERA MEDICAL, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
ETHICON | ||
SUBSTANTIALLY EQUIVALENT | 3 | |
ETHICON INC. | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
ETHICON, INC | ||
SUBSTANTIALLY EQUIVALENT | 1 |