510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K911163Substantially Equivalent

Imagyn Medical Videoscopy Syst W/irrig Pump/access

Imagyn Medical, Inc., San Clemente CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K911163 is the FDA 510(k) clearance record for IMAGYN MEDICAL VIDEOSCOPY SYST W/IRRIG PUMP/ACCESS, a class I device, cleared for Imagyn Medical, Inc. on under FDA product code FWF (Camera, Television, Endoscopic, Without Audio). FDA records list 19 510(k) clearances for Imagyn Medical, Inc., from to . As of , FDA records show no recalls naming K911163.

Clearance record

Decision date
Received
(80 days to decision)
Product code
FWF Camera, Television, Endoscopic, Without Audio
Regulation
21 CFR 878.4160
Device class
Class I
Review panel
General, Plastic Surgery
Applicant
Imagyn Medical, Inc. 920 Calle Negocio, San Clemente CA
Third party review
No

Clearances, product code FWF

Trailing 12 months

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

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