510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K860796Substantially Equivalent

Dispo-Urette

Roland J. Zwick, Inc., Palo Alto CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K860796 is the FDA 510(k) clearance record for DISPO-URETTE, a class II device, cleared for Roland J. Zwick, Inc. on under FDA product code PCF (Sampler, Endocervical). FDA's definition for product code PCF reads: "Obtains tissue samples from the endocervical canal for histological analysis". FDA records list 2 510(k) clearances for Roland J. Zwick, Inc., from to . As of , FDA records show no recalls naming K860796.

Clearance record

Decision date
Received
(35 days to decision)
Product code
PCF Sampler, Endocervical
Regulation
21 CFR 884.1050
Device class
Class II
Review panel
Obstetrics/Gynecology
Applicant
Roland J. Zwick, Inc. 450 San Antonion Rd., Suite 21, Palo Alto CA
Third party review
No

Clearances, product code PCF

Trailing 12 months

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

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