FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Altis Single Incision Sling System (519650); Aris Transobturator Sling System (519551); Supris Retropubic Sling System (519562)
K Number: K242473
·
Decision Oct 18, 2024
Classifications
1
FEI Numbers
15
Registration Numbers
15
Same Product Code
19
Applicant Total
54
Review Days
59
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Basic Information
- Device Name
- Altis Single Incision Sling System (519650); Aris Transobturator Sling System (519551); Supris Retropubic Sling System (519562)
- K Number
- K242473
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.3300
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Coloplast Corp.
- Date Received
- August 20, 2024
- Decision Date
- October 18, 2024
- Product Code
- PAH
- Advisory Committee
- General, Plastic Surgery
- Review Advisory Committee
- GU
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| PAH | Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Female, Mini-Sling | FDA class 2 | General, Plastic Surgery |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (PAH), ordered by most recent decision date.
Altis Single Incision Sling System
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Desara One Single Incision Sling System, 1 Pack ; Desara One Single Incision Sling System, 3 Pack
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
ALTIS SINGLE INCISION CLING SYSTEM
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
AJUST HELICAL ADJUSTABLE SINGLE-INCISION SLING
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
MINIARC PRO SINGLE-INCISION SLING SYSTEM
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
OPHIRA MINI SLING SYSTEM
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
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|---|---|---|---|
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| K242049 | SureCath Set | Nov 26, 2024 | Substantially Equivalent |
| K241210 | Luja Coude | Nov 21, 2024 | Substantially Equivalent |
| K242173 | Retrace Ureteral Access Sheath (ASXL10, ASXL12, ACXL10, ACXL12, AXXL10, AXXL12, ALXL10, ALXL12) | Nov 12, 2024 | Substantially Equivalent |
| K233411 | Folysil Silicone Catheter | Apr 15, 2024 | Substantially Equivalent |
| K231953 | Biatain Fiber Ag (33570 - 5 cm x 5 cm / 2 in x 2 in); Biatain Fiber Ag (33572 - 10 cm x 12 cm / 4 in x 5 in); Biatain Fiber Ag (33574 - 15 cm x 15 cm / 6 in x 6 in); Biatain Fiber Ag (33576 - 2.5 cm x 46 cm / 1 in x 18 in); Biatain Fiber Ag (33578 - 20 cm x 30 cm / 8 in x 12 in) | Mar 22, 2024 | Substantially Equivalent |
| K233101 | Luja Coude (20108 Male CH18 - large packaging) | Oct 26, 2023 | Substantially Equivalent |
| K213185 | ImaJin Silicone double loop ureteral stent kits, ImaJin Pyelostent Silicone double loop ureteral stent kits, ImaJin Stenostent Silicone double loop ureteral stent kits | Jun 8, 2022 | Unknown |