510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K832992Substantially Equivalent

Soffban Orthopedic Padding

Smith & Nephew, Inc., Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K832992 is the FDA 510(k) clearance record for SOFFBAN ORTHOPEDIC PADDING, a class I device, cleared for Smith & Nephew, Inc. on under FDA product code ITG (Bandage, Cast). FDA records list 572 510(k) clearances for Smith & Nephew, Inc., from to . As of , FDA records show no recalls naming K832992.

Clearance record

Decision date
Received
(73 days to decision)
Product code
ITG Bandage, Cast
Regulation
21 CFR 890.3025
Device class
Class I
Review panel
Physical Medicine
Applicant
Smith & Nephew, Inc. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code ITG

Trailing 12 months

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

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