510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K914912Substantially Equivalent

Promeon 63B Surgical Tape

Promeon, Brooklyn Center MN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K914912 is the FDA 510(k) clearance record for PROMEON 63B SURGICAL TAPE, a class I device, cleared for Promeon on under FDA product code KGX (Tape And Bandage, Adhesive). FDA records list one 510(k) clearance for Promeon. As of , FDA records show no recalls naming K914912.

Clearance record

Decision date
Received
(33 days to decision)
Product code
KGX Tape And Bandage, Adhesive
Regulation
21 CFR 880.5240
Device class
Class I
Review panel
General Hospital
Applicant
Promeon 6700 Shingle Creek Pkwy., Brooklyn Center MN
510(k) summary
Summary
Third party review
No

Clearances, product code KGX

Trailing 12 months

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

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