FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Glean Urodynamics System Male Delivery System (GUS-1000-M); Glean Urodynamics System Female Delivery System (GUS-1000-F); Glean Urodynamics System Uroflowmeter (UFM-1000 (Uroflowmeter))
K Number: K243052
·
Decision Mar 24, 2025
Classifications
1
FEI Numbers
13
Registration Numbers
13
Same Product Code
6
Applicant Total
1
Review Days
178
Basic Information
- Device Name
- Glean Urodynamics System Male Delivery System (GUS-1000-M); Glean Urodynamics System Female Delivery System (GUS-1000-F); Glean Urodynamics System Uroflowmeter (UFM-1000 (Uroflowmeter))
- K Number
- K243052
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.1620
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Bright Uro, Inc.
- Date Received
- September 27, 2024
- Decision Date
- March 24, 2025
- Product Code
- EXQ
- 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 |
|---|---|---|---|
| EXQ | Cystometer, Electrical Recording | FDA class 2 | Gastroenterology, Urology |
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