510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K922100Substantially Equivalent

Disposable Turp Fluid Containment Drape - Sterile

Graham Medical Products, Holyoke MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K922100 is the FDA 510(k) clearance record for DISPOSABLE TURP FLUID CONTAINMENT DRAPE - STERILE, a class II device, cleared for Graham Medical Products on under FDA product code EJJ (Alloy, Amalgam). FDA records list 9 510(k) clearances for Graham Medical Products, from to . As of , FDA records show no recalls naming K922100.

Clearance record

Decision date
Received
(315 days to decision)
Product code
EJJ Alloy, Amalgam
Regulation
21 CFR 872.3070
Device class
Class II
Review panel
Dental
Applicant
Graham Medical Products P.O. Box 510, 56 Canal St., Holyoke MA
510(k) summary
Statement
Third party review
No

Clearances, product code EJJ

Trailing 12 months

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

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