510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K912824Substantially Equivalent

Devon Sponge Counter Bags

Devon Industries, Inc., Chatsworth CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K912824 is the FDA 510(k) clearance record for DEVON SPONGE COUNTER BAGS, a class I device, cleared for Devon Industries, Inc. on under FDA product code LWH (Counter, Sponge, Surgical). FDA records list 47 510(k) clearances for Devon Industries, Inc., from to . As of , FDA records show no recalls naming K912824.

Clearance record

Decision date
Received
(61 days to decision)
Product code
LWH Counter, Sponge, Surgical
Regulation
21 CFR 880.2740
Device class
Class I
Review panel
General Hospital
Applicant
Devon Industries, Inc. 9530 De Soto Ave., Chatsworth CA
510(k) summary
Statement
Third party review
No

Clearances, product code LWH

Trailing 12 months

FDA records hold no clearances under product code LWH in the trailing twelve months.

FDA records show no clearances under product code LWH in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code LWH, 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 20260