FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
UROPASS URETERAL ACCESS SHEATH, MODEL 61224
K Number: K051593
·
Decision Sep 2, 2005
Classifications
1
FEI Numbers
38
Registration Numbers
38
Same Product Code
63
Applicant Total
16
Review Days
78
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Basic Information
- Device Name
- UROPASS URETERAL ACCESS SHEATH, MODEL 61224
- K Number
- K051593
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.5130
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Acmi Corporation
- Date Received
- June 16, 2005
- Decision Date
- September 2, 2005
- Product Code
- KNY
- 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 |
|---|---|---|---|
| KNY | Accessories, Catheter, G-U | FDA class 2 | Gastroenterology, Urology |
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Other Clearances by Acmi Corporation
| K Number | Device Name | ||
|---|---|---|---|
| K061975 | PLASMASEAL OPEN FORCEPS, MODELS 2103PK AND 91701PK | Aug 10, 2006 | Substantially Equivalent |
| K060752 | ACMI DUR-HL LASER SYSTEMS | May 25, 2006 | Substantially Equivalent |
| K060269 | ACMI DUR-DIGITAL URETEROSCOPE AND CHOLEDOCHOSCOPE SYSTEM | Mar 31, 2006 | Substantially Equivalent |
| K052044 | ACMI AUTOCLAVABLE URETEROSCOPE, MODELS MR-6A AND MR-6AL | Aug 16, 2005 | Substantially Equivalent |
| K043581 | DUAL LUMEN CATHETER | Mar 3, 2005 | Substantially Equivalent |
| K042069 | INVISIO IRL DIGITAL RIGID LAPAROSCOPE SYSTEM | Nov 1, 2004 | Substantially Equivalent |
| K042225 | ACMI INVISIO ICN, MODELS ICN-0564 AND ICN-0565 | Sep 10, 2004 | Substantially Equivalent |
| K031758 | ACMI M4 TELESCOPES | Sep 2, 2003 | Substantially Equivalent |
| K030960 | ECN ELECTRONIC VIDEO CYSTONEPHROSCOPE | Jul 16, 2003 | Substantially Equivalent |
| K030935 | BERKELEY V-10 VACUUM CURETTAGE SYSTEM | Jun 23, 2003 | Substantially Equivalent |