510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K000216Substantially Equivalent

Psk Endoscope Cleaning System

Psk Connectors Pty, Ltd., Kernersville NC / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K000216 is the FDA 510(k) clearance record for PSK ENDOSCOPE CLEANING SYSTEM, a class II device, cleared for Psk Connectors Pty, Ltd. on under FDA product code FEB (Accessories, Cleaning, For Endoscope). FDA's definition for product code FEB reads: "If the device is reusable, validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission (82 FR 26807, available at...". FDA records list one 510(k) clearance for Psk Connectors Pty, Ltd. As of , FDA records show no recalls naming K000216.

Clearance record

Decision date
Received
(106 days to decision)
Product code
FEB Accessories, Cleaning, For Endoscope
Regulation
21 CFR 876.1500
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Psk Connectors Pty, Ltd. 311 S. Main St., Kernersville NC
510(k) summary
Summary
Third party review
No

Clearances, product code FEB

Trailing 12 months
1 clearance under product code FEB in the twelve months to October 2026, October 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code FEB, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20261