510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K981958Substantially Equivalent

Leisegang Video Colposcope

Netoptix Corp., North Attleboro MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K981958 is the FDA 510(k) clearance record for LEISEGANG VIDEO COLPOSCOPE, a class II device, cleared for Netoptix Corp. on under FDA product code HEX (Colposcope (And Colpomicroscope)). FDA records list 4 510(k) clearances for Netoptix Corp., from to . As of , FDA records show no recalls naming K981958.

Clearance record

Decision date
Received
(137 days to decision)
Product code
HEX Colposcope (And Colpomicroscope)
Regulation
21 CFR 884.1630
Device class
Class II
Review panel
Obstetrics/Gynecology
Applicant
Netoptix Corp. 49 Plain St., North Attleboro MA
510(k) summary
Summary
Third party review
No

Clearances, product code HEX

Trailing 12 months

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

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