FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Smith & Nephew Tablet Application
K Number: K190367
·
Decision May 21, 2019
Classifications
1
FEI Numbers
1
Registration Numbers
1
Same Product Code
0
Applicant Total
16
Review Days
95
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Basic Information
- Device Name
- Smith & Nephew Tablet Application
- K Number
- K190367
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.1500
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Smith & Nephew
- Date Received
- February 15, 2019
- Decision Date
- May 21, 2019
- Product Code
- QGY
- Advisory Committee
- Gastroenterology, Urology
- Review Advisory Committee
- SU
- 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 |
|---|---|---|---|
| QGY | Mobile / Tablet Software Application To Control Settings Of Surgical And Endoscopic Camera | FDA class 2 | Gastroenterology, Urology |
Other Clearances by Smith & Nephew
| K Number | Device Name | ||
|---|---|---|---|
| K241666 | EVOS Pelvic and Acetabular System | Feb 19, 2025 | Substantially Equivalent |
| K240487 | EVOS Patella Plates | Sep 3, 2024 | Substantially Equivalent |
| K233730 | Footprint Mini PK, 3.5mm Suture Anchor | Jan 17, 2024 | Substantially Equivalent |
| K232457 | Q-FIX ULTRA All-Suture Anchor | Sep 8, 2023 | Substantially Equivalent |
| K223762 | Smith & Nephew ACCORD Cable System | May 30, 2023 | Substantially Equivalent |
| K203566 | Tablet Application | May 13, 2021 | Substantially Equivalent |
| K201253 | Modular Rail System, TAYLOR SPATIAL FRAME External Fixator, JET-X Fixator, ILIZAROV External Fixator, Other External Fixation | Dec 8, 2020 | Substantially Equivalent |
| K201349 | Smith+Nephew Arthroscopes | Jul 20, 2020 | Substantially Equivalent |
| K201198 | S+N Laparoscopes, 4KO, Autoclavable, S+N Bariactric Laparoscopes, 4KO, Autoclavable | Jul 17, 2020 | Substantially Equivalent |
| K192876 | INTELLIO Tablet Application | Feb 27, 2020 | Substantially Equivalent |