510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K253791Substantially Equivalent

PUREVUE™ Quick Connect Cannula System Tray; PUREVUE™ Quick Connect Cannula System Lid

DePuy Mitek, Inc., Raynham MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K253791 is the FDA 510(k) clearance record for PUREVUE™ Quick Connect Cannula System Tray; PUREVUE™ Quick Connect Cannula System Lid, a class II device, cleared for DePuy Mitek, Inc. on under FDA product code KCT (Sterilization Wrap Containers, Trays, Cassettes & Other Accessories). FDA records list 80 510(k) clearances for DePuy Mitek, Inc., from to . As of , FDA records show no recalls naming K253791.

Clearance record

Decision date
Received
(90 days to decision)
Product code
KCT Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
Regulation
21 CFR 880.6850
Device class
Class II
Review panel
General Hospital
Applicant
DePuy Mitek, Inc. 325 Paramount Dr., Raynham MA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code KCT

Trailing 12 months
8 clearances under product code KCT in the twelve months to October 2026, June 2026 the highest month at 3.
Show the numbers
Monthly 510(k) clearances under FDA product code KCT, trailing twelve months
MonthClearances
November 20251
December 20250
January 20260
February 20262
March 20260
April 20260
May 20260
June 20263
July 20260
August 20260
September 20262
October 20260