510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K955463Substantially Equivalent

Grip-a-Boots

Sil-Med Corp., Taunton MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K955463 is the FDA 510(k) clearance record for GRIP-A-BOOTS, a class I device, cleared for Sil-Med Corp. on under FDA product code LXZ (Guard, Instrument). FDA records list 29 510(k) clearances for Sil-Med Corp., from to . As of , FDA records show no recalls naming K955463.

Clearance record

Decision date
Received
(55 days to decision)
Product code
LXZ Guard, Instrument
Regulation
21 CFR 878.4800
Device class
Class I
Review panel
General, Plastic Surgery
Applicant
Sil-Med Corp. 700 Warner Blvd., Taunton MA
510(k) summary
Summary
Third party review
No

Clearances, product code LXZ

Trailing 12 months

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

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