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FDA 510(k)

ASEPT® Glide Peritoneal Drainage System

K-Number: K241278 · 2025-01-14

ApplicantPfm Medical, Inc.
Decision Date2025-01-14
Product CodePNG
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

ASEPT® Glide Peritoneal Drainage System is a medical device manufactured by Pfm Medical, Inc.. It received FDA 510(k) clearance on 2025-01-14 under approval number K241278. The device is classified under product code PNG. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ASEPT® Glide Peritoneal Drainage System?

ASEPT® Glide Peritoneal Drainage System is a medical device that received FDA 510(k) clearance on 2025-01-14. It is manufactured by Pfm Medical, Inc.. The 510(k) number is K241278.

When was ASEPT® Glide Peritoneal Drainage System approved by the FDA?

ASEPT® Glide Peritoneal Drainage System received FDA 510(k) clearance on 2025-01-14, under approval number K241278.

What company makes ASEPT® Glide Peritoneal Drainage System?

ASEPT® Glide Peritoneal Drainage System is manufactured by Pfm Medical, Inc..

What is the FDA product code for ASEPT® Glide Peritoneal Drainage System?

The FDA product code for ASEPT® Glide Peritoneal Drainage System is PNG.

Related Clinical Trials

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Other Devices by Pfm Medical, Inc.

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Related Devices (Code: PNG)

K162457Rocket Indwelling Peritoneal Catheter (IPC) Insertion KitRocket Medical Plc K160437PleurX Peritoneal Catheter SystemCare Fusion K152105Rocket IPC Insertion Set, Rocket IPC Mini Insertion SetRocket Medical Plc K201155PleurX Peritoneal Catheter SystemCare Fusion K212675Aspira Peritoneal Drainage SystemMerit Medical Systems, Inc. K230319Passio Pump Drainage SystemBearpac Medical

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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