510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K053583Substantially Equivalent

Optivia Hysteroscopic Introducer, Optivia Steerable Working Channel

Optivia Medical, LLC, Winston-Salem NC / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K053583 is the FDA 510(k) clearance record for OPTIVIA HYSTEROSCOPIC INTRODUCER, OPTIVIA STEERABLE WORKING CHANNEL, a class II device, cleared for Optivia Medical, LLC on under FDA product code HIH (Hysteroscope (And Accessories)). FDA records list one 510(k) clearance for Optivia Medical, LLC. As of , FDA records show no recalls naming K053583.

Clearance record

Decision date
Received
(98 days to decision)
Product code
HIH Hysteroscope (And Accessories)
Regulation
21 CFR 884.1690
Device class
Class II
Review panel
Obstetrics/Gynecology
Applicant
Optivia Medical, LLC 101 N. Chestnut St., Winston-Salem NC
510(k) summary
Summary PDF
Third party review
No

Clearances, product code HIH

Trailing 12 months
8 clearances under product code HIH in the twelve months to October 2026, September 2026 the highest month at 3.
Show the numbers
Monthly 510(k) clearances under FDA product code HIH, trailing twelve months
MonthClearances
November 20250
December 20251
January 20260
February 20261
March 20260
April 20260
May 20261
June 20261
July 20260
August 20261
September 20263
October 20260