LogoFDA 510(k) Search
K Number
K253445

Validate with FDA (Live)

Device Name
BD Surgiphor™ 1000 mL Antimicrobial Irrigation System (910120)
Manufacturer
Bd
Date Cleared
2026-02-20

(141 days)

Product Code
FQH
Regulation Number
880.5475
Type
Traditional
Panel
General & Plastic Surgery
Age Range
N/A
Reference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview

Loading...

§ 880.5475 Jet lavage.

(a)
Identification. A jet lavage is a device used to clean a wound by a pulsatile jet of sterile fluid. The device consists of the pulsing head, tubing to connect to a container of sterile fluid, and a means of propelling the fluid through the tubing, such as an electric roller pump.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 880.9.