510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K770697Substantially Equivalent

Colposcope System

Richard Wolf Medical Instruments Corp., Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K770697 is the FDA 510(k) clearance record for COLPOSCOPE SYSTEM, a class II device, cleared for Richard Wolf Medical Instruments Corp. on under FDA product code HEX (Colposcope (And Colpomicroscope)). FDA records list 153 510(k) clearances for Richard Wolf Medical Instruments Corp., from to . As of , FDA records show no recalls naming K770697.

Clearance record

Decision date
Received
(35 days to decision)
Product code
HEX Colposcope (And Colpomicroscope)
Regulation
21 CFR 884.1630
Device class
Class II
Review panel
Obstetrics/Gynecology
Applicant
Richard Wolf Medical Instruments Corp. 803 N. Front St. Suite 3, Mchenry IL
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