510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K960738Substantially Equivalent

Steritite Sealed Container(sc08f,sc06f,sc04f,sc08q,sc06q,sc04q,sc08h,sc06h,sc04h)

Engineered Custom Mfg., Inc., Ridgefield NJ / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K960738 is the FDA 510(k) clearance record for STERITITE SEALED CONTAINER(SC08F,SC06F,SC04F,SC08Q,SC06Q,SC04Q,SC08H,SC06H,SC04H), a class II device, cleared for Engineered Custom Mfg., Inc. on under FDA product code KCT (Sterilization Wrap Containers, Trays, Cassettes & Other Accessories). FDA records list one 510(k) clearance for Engineered Custom Mfg., Inc. As of , FDA records show one recall naming K960738.

Clearance record

Decision date
Received
(438 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
Engineered Custom Mfg., Inc. 65 Railroad Ave., Ridgefield NJ
510(k) summary
Statement
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