Question 1

Who is the manufacturer of CURITY SUPRAPUBIC DRAINAGE SYSTEM?

Accepted Answer

The Kendal Co. filed the 510(k) submission for CURITY SUPRAPUBIC DRAINAGE SYSTEM (K842899).

Question 2

What is the FDA product code for CURITY SUPRAPUBIC DRAINAGE SYSTEM?

Accepted Answer

LJE. as a Class U device in the GU panel.

Question 3

When was CURITY SUPRAPUBIC DRAINAGE SYSTEM cleared by the FDA?

Accepted Answer

Sep 10, 1984 (decision: SESE).

Question 4

What is the regulatory pathway for CURITY SUPRAPUBIC DRAINAGE SYSTEM?

Accepted Answer

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

Question 5

Who can help prepare an FDA 510(k) submission like CURITY SUPRAPUBIC DRAINAGE 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	K842899
Device Name	CURITY SUPRAPUBIC DRAINAGE SYSTEM
Applicant	The Kendal Co.
Product Code	LJE · GU
Decision Date	Sep 10, 1984
Decision	SESE
Submission Type	Traditional
Device Class	Class U

CURITY SUPRAPUBIC DRAINAGE SYSTEM

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