510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K946321Substantially Equivalent

Biostrip Sterile Wound Closure Strip

Cornelia Damsky, Inc., Stamford CT / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K946321 is the FDA 510(k) clearance record for BIOSTRIP STERILE WOUND CLOSURE STRIP, a class I device, cleared for Cornelia Damsky, Inc. on under FDA product code FPX (Strip, Adhesive, Closure, Skin). FDA records list 4 510(k) clearances for Cornelia Damsky, Inc., from to . As of , FDA records show no recalls naming K946321.

Clearance record

Decision date
Received
(15 days to decision)
Product code
FPX Strip, Adhesive, Closure, Skin
Regulation
21 CFR 880.5240
Device class
Class I
Review panel
General Hospital
Applicant
Cornelia Damsky, Inc. 56 Westcott Rd., Stamford CT
510(k) summary
Summary
Third party review
No

Clearances, product code FPX

Trailing 12 months

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

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