Definition: The Treatment Of Symptoms Due To Urinary Outflow Obstruction Secondary To Benign Prostatic Hyperplasia (BPH) In Men Age 50 And Above.
| Device Type ID | 2090 |
| Device Name | Implantable Transprostatic Tissue Retractor System |
| Physical State | Comprises Two Main Components, The Delivery Device And Implant. Each Delivery Device Comes Pre-loaded With One I\implant. The Delivery Device Is Inserted Into A 20F Cystoscopy Sheath Which Has Been Placed In The Male Urethra With The Sheath Tip Locat |
| Technical Method | Delivered Transurethrally Using A Rigid Delivery Device Which Is Used To Displace The Urethra Towards The Prostatic Capsule. The Implants Then Maintain The Approximated Position Of The Inner (urethral) Tissue And The Outer (capsular) Tissue Of The Pr |
| Target Area | Prostate |
| Regulation Description | Implantable Transprostatic Tissue Retractor System. |
| Regulation Medical Specialty | Gastroenterology/Urology |
| Review Panel | Gastroenterology/Urology |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Reproductive, Gastro-Renal, And Urological Devices (DRGUD) Urology And Lithotripsy Devices Branch (ULDB) |
| Submission Type | 510(k) |
| CFR Regulation Number | 876.5530 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | PEW |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | Yes |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 2090 |
| Device | Implantable Transprostatic Tissue Retractor System |
| Product Code | PEW |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Implantable Transprostatic Tissue Retractor System. |
| CFR Regulation Number | 876.5530 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
NEOTRACT, INC. | ||
SUBSTANTIALLY EQUIVALENT | 5 | |
| Device Problems | |
|---|---|
Adverse Event Without Identified Device Or Use Problem | 26 |
Device Handling Problem | 3 |
Use Of Device Problem | 2 |
Improper Or Incorrect Procedure Or Method | 2 |
Patient-Device Incompatibility | 1 |
Malposition Of Device | 1 |
| Total Device Problems | 35 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Neotract Inc | II | Dec-12-2018 |