FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
CONVEEN LEG BAG STRAP
K Number: K953783
·
Decision Sep 13, 1995
Classifications
1
FEI Numbers
119
Registration Numbers
119
Same Product Code
17
Applicant Total
54
Review Days
30
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
- CONVEEN LEG BAG STRAP
- K Number
- K953783
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 876.5250
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Coloplast Corp.
- Date Received
- August 14, 1995
- Decision Date
- September 13, 1995
- Product Code
- FAQ
- Advisory Committee
- Gastroenterology, Urology
- 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 |
|---|---|---|---|
| FAQ | Bag, Urine Collection, Leg, For External Use, Sterile | FDA class 1 | Gastroenterology, Urology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (FAQ), ordered by most recent decision date.
PROSYS CUSTOM FIT LEG BAG WITH PREATTACHED ADJUSTABLE INLET TUBE FOR PATIENT SIZING
FDA 510(k)
FDA Class 1
·Gastroenterology, Urology
CPR URINE BAG
FDA 510(k)
FDA Class 1
·Gastroenterology, Urology
CONVEEN URINE BAG - STERILE
FDA 510(k)
FDA Class 1
·Gastroenterology, Urology
PROSYS BEDSIDE DRAINAGE BAG
FDA 510(k)
FDA Class 1
·Gastroenterology, Urology
PROSYS LEG BAG
FDA 510(k)
FDA Class 1
·Gastroenterology, Urology
URINE COLLECTOR & ACCESSORIES
FDA 510(k)
FDA Class 1
·Gastroenterology, Urology
Other Clearances by Coloplast Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K252140 | Heylo System | Oct 6, 2025 | Substantially Equivalent |
| K251116 | Luja Coudé | Jun 27, 2025 | Substantially Equivalent |
| K250270 | Luja Set | Apr 17, 2025 | Substantially Equivalent |
| 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 |
| K242473 | Altis Single Incision Sling System (519650); Aris Transobturator Sling System (519551); Supris Retropubic Sling System (519562) | Oct 18, 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 |