510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K913365Substantially Equivalent

Accuscope(tm) & Accuscope Ii(tm)

Vineland Medical Products, Inc., Vineland NJ / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K913365 is the FDA 510(k) clearance record for ACCUSCOPE(TM) & ACCUSCOPE II(TM), a class II device, cleared for Vineland Medical Products, Inc. on under FDA product code HEX (Colposcope (And Colpomicroscope)). FDA records list one 510(k) clearance for Vineland Medical Products, Inc. As of , FDA records show no recalls naming K913365.

Clearance record

Decision date
Received
(273 days to decision)
Product code
HEX Colposcope (And Colpomicroscope)
Regulation
21 CFR 884.1630
Device class
Class II
Review panel
Obstetrics/Gynecology
Applicant
Vineland Medical Products, Inc. P.O. Box 575, Vineland NJ
510(k) summary
Statement
Third party review
No

Clearances, product code HEX

Trailing 12 months

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

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