510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K864189Substantially Equivalent

Ultra-Gel - #4083

John F. Greer Co., Inc., Oakland CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K864189 is the FDA 510(k) clearance record for ULTRA-GEL - #4083, a class I device, cleared for John F. Greer Co., Inc. on under FDA product code EXB (Collector, Ostomy). FDA records list 5 510(k) clearances for John F. Greer Co., Inc., from to . As of , FDA records show no recalls naming K864189.

Clearance record

Decision date
Received
(38 days to decision)
Product code
EXB Collector, Ostomy
Regulation
21 CFR 876.5900
Device class
Class I
Review panel
Gastroenterology, Urology
Applicant
John F. Greer Co., Inc. 530 E. 12th St., Oakland CA
Third party review
No

Clearances, product code EXB

Trailing 12 months

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

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