510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K934829Substantially Equivalent

Haskon Medical Grade Sheeting

Haskon Intl., Inc., Taunton MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K934829 is the FDA 510(k) clearance record for HASKON MEDICAL GRADE SHEETING, a class I device, cleared for Haskon Intl., Inc. on under FDA product code MDA (Elastomer, Silicone, For Scar Management). FDA records list one 510(k) clearance for Haskon Intl., Inc. As of , FDA records show no recalls naming K934829.

Clearance record

Decision date
Received
(118 days to decision)
Product code
MDA Elastomer, Silicone, For Scar Management
Regulation
21 CFR 878.4025
Device class
Class I
Review panel
General, Plastic Surgery
Applicant
Haskon Intl., Inc. 336 Weir St., Taunton MA
510(k) summary
Summary
Third party review
No

Clearances, product code MDA

Trailing 12 months

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

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