510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K992539Substantially Equivalent

Percuguard

Digit-Pro, Houston TX / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K992539 is the FDA 510(k) clearance record for PERCUGUARD, a class I device, cleared for Digit-Pro on under FDA product code LZB (Finger Cot). FDA records list one 510(k) clearance for Digit-Pro. As of , FDA records show no recalls naming K992539.

Clearance record

Decision date
Received
(203 days to decision)
Product code
LZB Finger Cot
Regulation
21 CFR 880.6250
Device class
Class I
Review panel
General Hospital
Applicant
Digit-Pro 10555 W. Little York Rd., Houston TX
510(k) summary
Statement
Third party review
No

Clearances, product code LZB

Trailing 12 months

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

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