FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
BARD SHORT RIGID URETEROSCOPE
K Number: K900813
·
Decision May 17, 1990
Classifications
1
FEI Numbers
120
Registration Numbers
120
Same Product Code
112
Applicant Total
645
Review Days
85
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Basic Information
- Device Name
- BARD SHORT RIGID URETEROSCOPE
- K Number
- K900813
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.1500
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Applicant
- C.R. Bard, Inc.
- Date Received
- February 21, 1990
- Decision Date
- May 17, 1990
- Product Code
- FGB
- 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 |
|---|---|---|---|
| FGB | Ureteroscope And Accessories, Flexible/Rigid | FDA class 2 | Gastroenterology, Urology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (FGB), ordered by most recent decision date.
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Single-Use Video Flexible Ureterorenoscope (RP-U-C03R9, RP-U-C03R3, RP-U-C03S9, RP-U-C03S3); Endoscopic Video Image Processor (RP-IPD-V2000EF); Endoscopic Video Image Processor (RP-IPD-V1000F)
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Flexible Ureterorenoscope system (Electronic Endoscope Image Processor, model: SP-TXCLQ12.1, Flexible Ureterorenoscope, model: SP-SNGSYJ 2.0, SP-SNGSYJ 2.2, SP-SNGSYJ 2.5, SP-SNGSYJ 2.8)
FDA 510(k)
FDA Class 2
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