FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SpeediCath Compact (28578, 28580, 28582, 28584), SpeediCath Compact Plus (28810, 28812, 28814)
K Number: K203637
·
Decision Mar 8, 2022
Classifications
1
FEI Numbers
87
Registration Numbers
87
Same Product Code
72
Applicant Total
15
Review Days
449
Basic Information
- Device Name
- SpeediCath Compact (28578, 28580, 28582, 28584), SpeediCath Compact Plus (28810, 28812, 28814)
- K Number
- K203637
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.5130
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Coloplast
- Date Received
- December 14, 2020
- Decision Date
- March 8, 2022
- Product Code
- EZD
- 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 |
|---|---|---|---|
| EZD | Catheter, Straight | FDA class 2 | Gastroenterology, Urology |
Similar 510(k) Clearances
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Cure Twist Female 8 Catheter (T8); Cure Twist Female 10 Catheter (T10); Cure Twist Female 12 Catheter (T12); Cure Twist Female 14 Catheter (T14); Cure Twist Female 16 Catheter (T16); Cure Twist Female 8 Catheter Kit with supplies (T8K); Cure Twist Female 10 Catheter Kit with supplies (T10K); Cure Twist Female 12 Catheter Kit with supplies (T12K); Cure Twist Female 14 Catheter Kit with supplies (T14K); Cure Twist Female 16 Catheter Kit with supplies (T16K)
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Luja female (20051); Luja female (20052); Luja female (20054); Luja female (20056)
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Other Clearances by Coloplast
| K Number | Device Name | ||
|---|---|---|---|
| K241028 | Luja female (20051); Luja female (20052); Luja female (20054); Luja female (20056) | Jul 26, 2024 | Substantially Equivalent |
| K231891 | Virtue Male Sling System with Alexis Wound Retractor Convenience Kit | Sep 25, 2023 | Unknown |
| K230165 | Luja Coudé (20118 Male CH8 - small packaging (Pocket size)), Luja Coudé (20111 Male CH10 - small packaging (Pocket size)), Luja Coudé (20112 Male CH12 - small packaging (Pocket size)), Luja Coudé (20114 Male CH14 - small packaging (Pocket size)), Luja Coudé (20101 Male CH10 - large packaging), Luja Coudé (20102 Male CH12 - large packaging), Luja Coudé (20104 Male CH14 - large packaging), Luja Coudé (20106 Male CH16 - large packaging) | Aug 25, 2023 | Substantially Equivalent |
| K223821 | Self-Cath Closed System | Aug 2, 2023 | Substantially Equivalent |
| K221401 | Self-Cath and Self-Cath Plus | Dec 2, 2022 | Substantially Equivalent |
| K222059 | SpeediCath Flex Set | Sep 21, 2022 | Substantially Equivalent |
| K210250 | SpeedCath Compact Male | Apr 26, 2022 | Substantially Equivalent |
| K200820 | SpeediCath Compact Set | Nov 13, 2020 | Substantially Equivalent |
| K192904 | SpeediCath Compact Set | Nov 2, 2020 | Substantially Equivalent |
| K200142 | SpeediCath Soft | Jul 30, 2020 | Substantially Equivalent |