510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K903002Substantially Equivalent

Probet (Tm)

Gynopharma, Inc., Princeton NJ / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K903002 is the FDA 510(k) clearance record for PROBET (TM), a class II device, cleared for Gynopharma, Inc. on under FDA product code HFF (Aspirator, Endometrial). FDA records list 2 510(k) clearances for Gynopharma, Inc., from to . As of , FDA records show no recalls naming K903002.

Clearance record

Decision date
Received
(270 days to decision)
Product code
HFF Aspirator, Endometrial
Regulation
21 CFR 884.1060
Device class
Class II
Review panel
Obstetrics/Gynecology
Applicant
Gynopharma, Inc. C/O Ellis Pharm Consulting Inc, Princeton NJ
Third party review
No

Clearances, product code HFF

Trailing 12 months

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

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