Question 1

Who is the manufacturer of INTELIJET TM FLUID MANAGEMENT SYSTEM?

Accepted Answer

Smith & Nephew Dyonics, Inc. filed the 510(k) submission for INTELIJET TM FLUID MANAGEMENT SYSTEM (K912453).

Question 2

What is the FDA product code for INTELIJET TM FLUID MANAGEMENT SYSTEM?

Accepted Answer

HRX. It is classified under 21 CFR 888.1100 as a Class 2 device in the Orthopedic panel.

Question 3

When was INTELIJET TM FLUID MANAGEMENT SYSTEM cleared by the FDA?

Accepted Answer

Aug 26, 1991 (decision: SESE).

Question 4

What is the regulatory pathway for INTELIJET TM FLUID MANAGEMENT SYSTEM?

Accepted Answer

510(k) clearance (submission type: Traditional).

Question 5

Who can help prepare an FDA 510(k) submission like INTELIJET TM FLUID MANAGEMENT SYSTEM?

Accepted Answer

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Record ID	K912453
Device Name	INTELIJET TM FLUID MANAGEMENT SYSTEM
Applicant	Smith & Nephew Dyonics, Inc.
Product Code	HRX · Orthopedic
Decision Date	Aug 26, 1991
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 888.1100
Device Class	Class 2

INTELIJET TM FLUID MANAGEMENT SYSTEM

Device Facts

Regulatory Classification

Identification