FDA 510(k)
FDA class 2
Substantially Equivalent
🇩🇰 Denmark
LiNA CystoVu HD (CYV-100-5; CYV-101-5); LiNA ScopeVu (SCP-100-1)
K Number: K240227
·
Decision Aug 22, 2024
Classifications
1
FEI Numbers
136
Registration Numbers
136
Same Product Code
91
Applicant Total
16
Review Days
209
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Basic Information
- Device Name
- LiNA CystoVu HD (CYV-100-5; CYV-101-5); LiNA ScopeVu (SCP-100-1)
- K Number
- K240227
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.1500
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Lina Medical Aps
- Date Received
- January 26, 2024
- Decision Date
- August 22, 2024
- Product Code
- FAJ
- 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 |
|---|---|---|---|
| FAJ | Cystoscope And Accessories, Flexible/Rigid | FDA class 2 | Gastroenterology, Urology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (FAJ), ordered by most recent decision date.
OES ELITE Cystoscope and Accessories; Obturator, 17 Fr. (WA2C17BO); Obturator, 19.8 Fr. (WA2C19BO); Obturator, 21 Fr. (WA2C21BO); Obturator, 21 Fr., for sheath with ramp (WA2C21RO); Obturator, 21 Fr., long (WA2C21LO); Obturator, 21 Fr., for straight sheath (WA2C21SO); Obturator, 22.5 Fr. (WA2C22BO); Obturator, 25 Fr. (WA2C25BO); Obturator, optical, 19.8 Fr. (WA2C19BV); Obturator, optical, 21 Fr. (WA2C21BV); Obturator, optical, 21 Fr., for straight sheath (WA2C21SV); Obturator, optical,
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
CFlex Cystoscope - Standard Deflection (0570-0455); CFlex Cystoscope - Reverse Deflection (0570-0456); CystoView Monitor (0570-0465)
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Strauss Surgical Cystoscopes & Hysteroscopes (STS-2040-302ASA HD-endoscope, 4 x 302 mm, view. Dir. 0°, standard, autoclavable); Strauss Surgical Cystoscopes & Hysteroscopes (STS-2040-302AA HD-endoscope, 4 x 302 mm, view. Dir. 0°, wide angle, autoclavable); Strauss Surgical Cystoscopes & Hysteroscopes (STS-2040-302BA HD-endoscope, 4 x 302 mm, view. Dir. 30°, wide angle, autoclavable); Strauss Surgical Cystoscopes & Hysteroscopes (STS-2040-302BSA HD-endoscope, 4 x 302 mm, view. Dir. 30°,
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
PrimeSight UltraView System
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Strauss Surgical cystoscope, hysteroscope and accessories Instruments
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
UV5000W Handle
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
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|---|---|---|---|
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| K193007 | LiNA OperaScope with HDMI cable and on-board LCD - 6 units, LiNA OperaScope Recording Module | Jan 17, 2020 | Substantially Equivalent |
| K182224 | SafeAir Smoke Evacuator compact | Feb 7, 2019 | Substantially Equivalent |
| K182354 | SafeAir Telescopic Smoke Pencil | Dec 14, 2018 | Substantially Equivalent |
| K171113 | LiNA OperaScope with HDMI cable and on-board LCD-single unit, LiNA OperaScope with HDMI cable and on-board LCD-6 units, LiNA OperaScope Recording Module | Jan 4, 2018 | Substantially Equivalent |
| K143145 | SafeAir Smoke Pencil | Dec 4, 2014 | Substantially Equivalent |
| K142757 | LiNA PowerBlade Plus HC | Oct 23, 2014 | Substantially Equivalent |
| K142538 | LiNA SafeAir Smoke Pencil | Oct 6, 2014 | Substantially Equivalent |
| K132135 | LINA GOLD LOOP HC | Jan 31, 2014 | Substantially Equivalent |