510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K905115Substantially Equivalent

Biovision Endocular Probe

Douglas James Donaldson Compliance Services, Oakland CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K905115 is the FDA 510(k) clearance record for BIOVISION ENDOCULAR PROBE, a class II device, cleared for Douglas James Donaldson Compliance Services on under FDA product code HGF (Source, Abortion Unit, Vacuum). FDA records list 5 510(k) clearances for Douglas James Donaldson Compliance Services, from to . As of , FDA records show no recalls naming K905115.

Clearance record

Decision date
Received
(90 days to decision)
Product code
HGF Source, Abortion Unit, Vacuum
Regulation
21 CFR 884.5070
Device class
Class II
Review panel
Obstetrics/Gynecology
Applicant
Douglas James Donaldson Compliance Services 100 Hegenberger Rd.,, Oakland CA
Third party review
No

Clearances, product code HGF

Trailing 12 months

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

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