510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K950639Substantially Equivalent

Karl Storz Infant, Balloon Vaginoscope, Vaginoscope Sheath, Fiber Optic Light Carriers, Adjustable Magnifiers

Karl Storz Endoscopy-America, Inc., Culver City CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K950639 is the FDA 510(k) clearance record for KARL STORZ INFANT, BALLOON VAGINOSCOPE, VAGINOSCOPE SHEATH, FIBER OPTIC LIGHT CARRIERS, ADJUSTABLE MAGNIFIERS, a class II device, cleared for KARL STORZ Endoscopy-America, Inc. on under FDA product code MOK (Vaginoscope And Accessories). FDA records list 402 510(k) clearances for KARL STORZ Endoscopy-America, Inc., from to . As of , FDA records show no recalls naming K950639.

Clearance record

Decision date
Received
(126 days to decision)
Product code
MOK Vaginoscope And Accessories
Regulation
21 CFR 884.1630
Device class
Class II
Review panel
Obstetrics/Gynecology
Applicant
KARL STORZ Endoscopy-America, Inc. 600 Corporate Pt.e, Culver City CA
510(k) summary
Summary
Third party review
No

Clearances, product code MOK

Trailing 12 months

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

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