510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K111681Substantially Equivalent

Histobrush

Puritan Medical Products Company, LLC, Guilford ME / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K111681 is the FDA 510(k) clearance record for HISTOBRUSH, a class II device, cleared for Puritan Medical Products Company, LLC on under FDA product code HHT (Spatula, Cervical, Cytological). FDA records list 8 510(k) clearances for Puritan Medical Products Company, LLC, from to . As of , FDA records show no recalls naming K111681.

Clearance record

Decision date
Received
(218 days to decision)
Product code
HHT Spatula, Cervical, Cytological
Regulation
21 CFR 884.4530
Device class
Class II
Review panel
Obstetrics/Gynecology
Applicant
Puritan Medical Products Company, LLC 31 School St., Guilford ME
510(k) summary
Summary PDF
Third party review
No

Clearances, product code HHT

Trailing 12 months

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

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