510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K932184Substantially Equivalent

Sterile Lemaitre Glow 'N Tell Tape

Vascutech, Inc., North Andover MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K932184 is the FDA 510(k) clearance record for STERILE LEMAITRE GLOW 'N TELL TAPE, a class II device, cleared for Vascutech, Inc. on under FDA product code KFX (Assembly, Thigh/Knee/Shank/Ankle/Foot, External). FDA records list 14 510(k) clearances for Vascutech, Inc., from to . As of , FDA records show 6 recalls naming K932184.

Clearance record

Decision date
Received
(78 days to decision)
Product code
KFX Assembly, Thigh/Knee/Shank/Ankle/Foot, External
Regulation
21 CFR 890.3500
Device class
Class II
Review panel
Physical Medicine
Applicant
Vascutech, Inc. 790 Tpke. St., North Andover MA
510(k) summary
Statement
Third party review
No

Clearances, product code KFX

Trailing 12 months

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

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