Product code PNG— Gastroenterology, Urology
ASPIRA PERITONEAL DRAINAGE SYSTEM
- Classification name
- Peritoneal, Drainage Catheter For Refractory Ascites, Long-Term Indwelling
- Device class
- Class 2
- Regulation
- 21 CFR 876.5630
- Advisory panel
- Gastroenterology, Urology
- Total cleared
- 15
- First cleared
- Most recent
FDA classification definition
“For drainage of refractory ascites with long-term occurrence from the peritoneal cavity.”
Market context for product code PNG
FDA has cleared devices under product code PNG between 2005 and 2025, filed by 8 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
- 2025
- 2024
- 2023
- 2021
- 2020
- 2016
- 2012
- 2011
- 2010
- 2008
- 2005
Top applicants under product code PNG
Recent clearances under product code PNG
- K241278 — ASEPT® Glide Peritoneal Drainage System
- K241946 — PeritX 1L Drainage Kit (90-1010) +12 more
- K230319 — Passio Pump Drainage System
- K221779 — ASEPT Peritoneal Drainage System
- K212675 — Aspira Peritoneal Drainage System
- K201155 — PleurX Peritoneal Catheter System
- K162457 — Rocket Indwelling Peritoneal Catheter (IPC) Insertion Kit
- K160437 — PleurX Peritoneal Catheter System
- K152105 — Rocket IPC Insertion Set, Rocket IPC Mini Insertion Set
- K122422 — PLEURX PLEURAL CATHETER SYSTEM PLEURX CATHETER ACCESS KIT PLEURX SLIDE VALVED PEELABLE INTRODUCER
- K113854 — PLEURX PERITONEAL CATHETER SYSTEM
- K110396 — ASPIRA PERITONEAL DRAINAGE SYSTEM
- K093796 — ASEPT PERITONEAL DRAINAGE SYSTEM
- K081288 — ASPIRA PERITONEAL DRAINAGE SYSTEM
- K051711 — PLEURX PERITONEAL CATHETER KIT AND PLEURX DRAINAGE KITS
Data sourced from openFDA. This site is unofficial and independent of the FDA.