FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
DA VINCI SONICPRO CLEANING SYSTEM, MODEL 400253
K Number: K073112
·
Decision Aug 1, 2008
Classifications
1
FEI Numbers
7
Registration Numbers
7
Same Product Code
11
Applicant Total
176
Review Days
270
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Basic Information
- Device Name
- DA VINCI SONICPRO CLEANING SYSTEM, MODEL 400253
- K Number
- K073112
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.1500
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Intuitive Surgical, Inc.
- Date Received
- November 5, 2007
- Decision Date
- August 1, 2008
- Product Code
- NVE
- Advisory Committee
- Gastroenterology, Urology
- Review Advisory Committee
- HO
- 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 |
|---|---|---|---|
| NVE | Washer, Cleaner, Automated, Endoscope | FDA class 2 | Gastroenterology, Urology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (NVE), ordered by most recent decision date.
AMSCO 600 Steam Sterilizer, V-PRO maX 2 Low Temperature Sterilization System, V-PRO s2 Low Temperature Sterilization System, V-PRO 60 Low Temperature Sterilization System, RAS 12 Rack, RAS 12 Long Rack, RAS Cycle of the AMSCO 7052HP and 7053HP Single Chamber Washer Disinfector
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
AMSCO 600 Steam Sterilizer, V-PRO maX 2 Low Temperature Sterilization System, V-PRO s2 Low Temperature Sterilization System, RAS 12 Rack, RAS 12 Long Rack, RAS Cycle of the AMSCO 7052HP and 7053HP Single Chamber Washer Disinfector
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
RAS 12 Rack / RAS 12 Long Rack, used in RAS Cycle of AMSCO 7052HP / 7053HP Single Chamber Washer-Disinfector
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
RAS 12 Rack, RAS 12 Long Rack, RAS Cycle of the AMSCO 7052HP/7053HP Single Chamber Washer/Disinfector
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
RAS 12 Rack, RAS 12 Long Rack; RAS Cycle of AMSCO 7052HP/7053HP Single Chamber Washer/Disinfector
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
MANZI CLEANER SYSTEM
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
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| K252675 | da Vinci SP Surgical System (SP1098) | Dec 15, 2025 | Substantially Equivalent |
| K252069 | da Vinci SP Surgical System (SP1098) | Dec 2, 2025 | Substantially Equivalent |
| K251426 | da Vinci SP Surgical System (SP1098) | Oct 3, 2025 | Substantially Equivalent |
| K252045 | Ion Endoluminal System (IF1000) | Sep 23, 2025 | Substantially Equivalent |
| K251817 | da Vinci SP Surgical System (SP1098) | Sep 10, 2025 | Substantially Equivalent |