510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K062563Substantially Equivalent

Femten Cervical Tenaculum

Fem Suite, LLC, Port Townsend WA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K062563 is the FDA 510(k) clearance record for FEMTEN CERVICAL TENACULUM, a class II device, cleared for Fem Suite, LLC on under FDA product code HDC (Tenaculum, Uterine). FDA records list 2 510(k) clearances for Fem Suite, LLC, from to . As of , FDA records show no recalls naming K062563.

Clearance record

Decision date
Received
(260 days to decision)
Product code
HDC Tenaculum, Uterine
Regulation
21 CFR 884.4530
Device class
Class II
Review panel
Obstetrics/Gynecology
Applicant
Fem Suite, LLC 1530 Holcomb St., Port Townsend WA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code HDC

Trailing 12 months

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

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