FDA 510(k)
FDA class 2
Unknown
🇬🇧 United Kingdom
Rocket Indwelling Peritoneal Catheter (IPC) Insertion Kit
K Number: K162457
·
Decision Nov 14, 2016
Classifications
1
FEI Numbers
28
Registration Numbers
28
Same Product Code
14
Applicant Total
19
Review Days
73
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Basic Information
- Device Name
- Rocket Indwelling Peritoneal Catheter (IPC) Insertion Kit
- K Number
- K162457
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.5630
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Unknown
- Statement or Summary
- Summary
- Applicant
- Rocket Medical Plc
- Date Received
- September 2, 2016
- Decision Date
- November 14, 2016
- Product Code
- PNG
- 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 |
|---|---|---|---|
| PNG | Peritoneal, Drainage Catheter For Refractory Ascites, Long-Term Indwelling | FDA class 2 | Gastroenterology, Urology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (PNG), ordered by most recent decision date.
ASEPT® Glide Peritoneal Drainage System
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FDA Class 2
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PeritX 1L Drainage Kit (90-1010); PeritX 2L Drainage Kit (90-2010); PeritX Peritoneal Catheter Kit (50-9000C); PeritX Peritoneal Catheter and Starter Kit (50-9900C); PeritX Peritoneal Catheter Mini Kit (50-9050A); PleurX Low Profile Catheter Mini Kit (50-8050); Valve Cap (50-7235A); PeritX Valve Kit (50-7272); Catheter Access Kit (50-7280A); Lockable Drainage Line (50-7245A); Lockable Drainage Line Kit (50-7265A); PleurX Supplemental Insertion Kit (50-7262); Procedure Pack (50-
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Passio Pump Drainage System
FDA 510(k)
FDA Class 2
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ASEPT Peritoneal Drainage System
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Aspira Peritoneal Drainage System
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
PleurX Peritoneal Catheter System
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Other Clearances by Rocket Medical Plc
| K Number | Device Name | ||
|---|---|---|---|
| K210509 | Rocket Platinum Cured Cathter | Sep 9, 2021 | Unknown |
| K163321 | Rocket Indwelling Pleural Catheter (IPC) Insertion Kit | Aug 17, 2017 | Substantially Equivalent |
| K152105 | Rocket IPC Insertion Set, Rocket IPC Mini Insertion Set | Mar 29, 2016 | Unknown |
| K123033 | ROCKET IPC INSERTION PACK, ROCKET IPC MINI INSERTION SET, ROCKET IPC DRESSING PACK AND BOTTLE SET, ROCKET IPC DRAINAGE B | Feb 1, 2013 | Substantially Equivalent |
| K052365 | CERVINEEDLE DISPOSABLE CARTRIDGE SYRINGE | Oct 17, 2005 | Substantially Equivalent |
| K042264 | GUIDEWIRES | Nov 24, 2004 | Substantially Equivalent |
| K040189 | ENDOMETRIAL SAMPLING SYRINGE | Oct 4, 2004 | Substantially Equivalent |
| K032015 | EMBRYON ULTRASOUND NEEDLE GUIDE | Aug 8, 2003 | Substantially Equivalent |
| K000205 | EMBRYON SINGLE AND DOUBLE LUMEN NEEDLES | Apr 19, 2000 | Substantially Equivalent |
| K000340 | HYSTALOG HSG CATHETER | Apr 19, 2000 | Substantially Equivalent |