510(k) K073646
- Device
- MINITAPE URETHRAL SLING
- Applicant
- MPATHY MEDICAL DEVICES, LTD.
- 510(k) number
- K073646
- Product code
- PAH
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2008-02-25
- Date received
- 2007-12-26
- Regulation
- 878.3300
- Classification name
- Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Female, Mini-sling
- Medical specialty
- General & Plastic Surgery
- Review panel
- Gastroenterology/Urology
- Device class
- 2
- Clearance type
- Special
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- LOUIS J MAZZARESE
- Address
- 24 Barberry Ln. Madison CT US 06443 06443
FDA Registration Numbers#
- 3003990090
- 2125050
- 1000121056
- 2529647
- 1018233
- 2183744
- 3016678045
- 1828132
- 3021632375
- 9681260
- 2124215
- 3004838863
- 3005099803
- 3006621295
- 3004612223
Source Documents#
Other 510(k) Records For Product Code PAH #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K242473 | Altis Single Incision Sling System (519650); Aris Transobturator Sling System (519551); Supris Retropubic Sling System (519562) | Coloplast Corp. | 2024-10-18 |
| K221874 | Altis Single Incision Sling System | Coloplast A/S | 2023-02-15 |
| K191416 | Desara One Single Incision Sling System, 1 Pack ; Desara One Single Incision Sling System, 3 Pack | Caldera Medical, Inc. | 2020-02-07 |
| K121562 | ALTIS SINGLE INCISION CLING SYSTEM | Coloplast A/S | 2012-11-05 |
| K123179 | AJUST HELICAL ADJUSTABLE SINGLE-INCISION SLING | C.R. Bard, Inc. | 2012-11-02 |
| K121641 | MINIARC PRO SINGLE-INCISION SLING SYSTEM | American Medical Systems | 2012-09-07 |
| K110420 | OPHIRA MINI SLING SYSTEM | Promedon S.A | 2012-05-08 |
| K103418 | DESARA MINI | Caldera Medical, Inc. | 2011-11-30 |
| K100807 | MINIARC PRECISE SINGLE-INCISION SLING SYSTEM MODEL: 720181, 720191 | American Medical Systems, Inc. | 2010-06-07 |
| K092607 | AJUST ADJUSTABLE SINGLE INCISION SLING | C.R. Bard, Inc. | 2009-11-20 |
| K091180 | MINITAPE URETHRAL SLING | Mpathy Medical Devices, Ltd. | 2009-07-14 |
| K081275 | BOSTON SCIENTIFIC SURGICAL MESH | Boston Scientific Corp | 2008-08-27 |
| K073703 | AMS MINIARC SLING SYSTEM | American Medical Systems, Inc. | 2008-01-30 |
| K071902 | AMS MINIARC SLING SYSTEM | American Medical Systems, Inc. | 2007-08-24 |
| K070065 | AMS SINGLE INCISION SLING SYSTEM (SIS-0) | American Medical Systems, Inc. | 2007-03-01 |
Legacy Summary#
summary
FDA Review#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases