FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Altis Single Incision Sling System
K Number: K221874
·
Decision Feb 15, 2023
Classifications
1
FEI Numbers
15
Registration Numbers
15
Same Product Code
19
Applicant Total
71
Review Days
232
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- Altis Single Incision Sling System
- K Number
- K221874
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 878.3300
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Coloplast A/S
- Date Received
- June 28, 2022
- Decision Date
- February 15, 2023
- 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 (519650); Aris Transobturator Sling System (519551); Supris Retropubic Sling System (519562)
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
Other Clearances by Coloplast A/S
| K Number | Device Name | ||
|---|---|---|---|
| K220420 | Saffron Fixation System | Jun 10, 2022 | Substantially Equivalent |
| K191536 | Biatain Silicone Ag | Feb 21, 2020 | Substantially Equivalent |
| K181811 | ReTrace Ureteral Access Sheath | Sep 7, 2018 | Substantially Equivalent |
| K173527 | Digitex Delivery Device | Feb 12, 2018 | Substantially Equivalent |
| K140310 | Peristeen Anal Irrigation System | Sep 3, 2015 | Substantially Equivalent |
| K150935 | SpeediCath Compact Eve | Jul 2, 2015 | Substantially Equivalent |
| K150927 | Orchestra Hydrophilic Guidewire standard angled, Orchestra Hydrophilic Guidewire straight stiff, Orchestra Hydrophilic Guidewire angled stiff,Orchestra Hydrophilic Guidewire standard straight, Orchestra Hydrophilic Guidewire straight stiff | May 27, 2015 | Substantially Equivalent |
| K143182 | Speedicath Compact Male | Jan 20, 2015 | Substantially Equivalent |
| K140523 | RE-TRACE URETERAL ACCESS SHEATH, 12/14 CH/FR, LENGTH 35 CM, LENGTH 45 CM | Jul 24, 2014 | Substantially Equivalent |
| K140116 | RESTORELLE Y CONTOUR MESH | Feb 12, 2014 | Substantially Equivalent |