Smith & Nephew Tablet Application
FDA 510(k) K190367 · Smith & Nephew
510(k) numberK190367
Submission
- Device name
- Smith & Nephew Tablet Application
- Applicant
- Smith & Nephew
Andover, MA, US - Received
- February 15, 2019
- Decision date
- May 21, 2019
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- QGY – Mobile / Tablet Software Application To Control Settings Of Surgical And Endoscopic Camera
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.1500
- Specialty
- Gastroenterology, Urology
Device is intended for wireless control of settings for surgical or endoscopic camera control unit and patient information system.
More from Smith & Nephew
| 510(k) | Device | Decision |
|---|---|---|
| K261462 | LANDMARK Total Knee SystemMBH · Traditional | 09/08/2026SE |
| K261968 | Q-FIX KNOTLESS All-Suture Anchor, 2.8mm, with one black knotless and one blue MINITAPE…MBI · Special | 07/09/2026SE |
| K254084 | AETOS Shoulder System - CONCELOC GlenoidsKWS · Traditional | 04/06/2026SE |
| K252416 | AETOS Shoulder System Meta Humeral Prosthesis Size 0KWS · Traditional | 10/29/2025SE |
| K252129 | AETOS Shoulder System Stemless Humeral ProsthesisPKC · Traditional | 10/03/2025SE |
| K251627 | BIORAPTOR 2.3 PK Suture Anchor w/ ULTRABRAID (#2) Suture (cobraid blue); BIORAPTOR 2.3…MBI · Special | 06/25/2025SE |
| K243608 | TRIGEN Stable Lock Nut & WasherJDS · Traditional | 06/12/2025SE |
| K250677 | LEGION Total Knee SystemJWH · Special | 04/02/2025SE |
| K250571 | CATALYSTEM Femoral StemsLZO · Special | 03/28/2025SE |
| K241666 | EVOS Pelvic and Acetabular SystemHRS · Traditional | 02/19/2025SE |
Questions and answers
When was Smith & Nephew Tablet Application cleared by the FDA?
Smith & Nephew Tablet Application (K190367) received a 510(k) decision of Substantially Equivalent on May 21, 2019, 95 days after the submission was received.
What is the product code of K190367?
The FDA product code is QGY – Mobile / Tablet Software Application To Control Settings Of Surgical And Endoscopic Camera, a Class II (moderate risk) device regulated under 21 CFR 876.1500.