510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K081522Substantially Equivalent

Bio Nuclear Diagnostics (Endo)cervical Sampler for Gyn Cytology

Bio Nuclear Diagnostics, Inc., Toronto, Ontario, CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K081522 is the FDA 510(k) clearance record for BIO NUCLEAR DIAGNOSTICS (ENDO)CERVICAL SAMPLER FOR GYN CYTOLOGY, a class II device, cleared for Bio Nuclear Diagnostics, Inc. on under FDA product code HHT (Spatula, Cervical, Cytological). FDA records list one 510(k) clearance for Bio Nuclear Diagnostics, Inc. As of , FDA records show no recalls naming K081522.

Clearance record

Decision date
Received
(189 days to decision)
Product code
HHT Spatula, Cervical, Cytological
Regulation
21 CFR 884.4530
Device class
Class II
Review panel
Obstetrics/Gynecology
Applicant
Bio Nuclear Diagnostics, Inc. 1791 Albion Rd., Toronto, Ontario, CA
510(k) summary
Statement
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