510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K881477Substantially Equivalent

Histogrip & Histogrip Gold Concentrate/prediluted

Stat Path, Riderwood MD / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K881477 is the FDA 510(k) clearance record for HISTOGRIP & HISTOGRIP GOLD CONCENTRATE/PREDILUTED, a class I device, cleared for Stat Path on under FDA product code KEL (Adhesive, Albumin-Based). FDA records list 4 510(k) clearances for Stat Path, from to . As of , FDA records show no recalls naming K881477.

Clearance record

Decision date
Received
(11 days to decision)
Product code
KEL Adhesive, Albumin-Based
Regulation
21 CFR 864.4010
Device class
Class I
Review panel
Pathology
Applicant
Stat Path P.O. Box 6, Riderwood MD
Third party review
No

Clearances, product code KEL

Trailing 12 months

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

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