FDA 510(k)
FDA class 2
Substantially Equivalent
🇬🇧 United Kingdom
SleeveLUX 24 Anoscope/Proctoscope (P2001); SleeveLUX 16 Anoscope/Proctoscope (P2002)
K Number: K250645
·
Decision Oct 9, 2025
Classifications
1
FEI Numbers
47
Registration Numbers
47
Same Product Code
26
Applicant Total
2
Review Days
219
Basic Information
- Device Name
- SleeveLUX 24 Anoscope/Proctoscope (P2001); SleeveLUX 16 Anoscope/Proctoscope (P2002)
- K Number
- K250645
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.1500
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Haemoband Surgical, Ltd.
- Date Received
- March 4, 2025
- Decision Date
- October 9, 2025
- Product Code
- FER
- 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 |
|---|---|---|---|
| FER | Anoscope And Accessories | FDA class 2 | Gastroenterology, Urology |
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Other Clearances by Haemoband Surgical, Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K091519 | HAEMOBAND MULTI-LIGATOR | Jul 28, 2009 | Substantially Equivalent |