510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K940152Substantially Equivalent

Camera Cover with Tear Tip

Hydro-Med Products, Inc., Dallas TX / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K940152 is the FDA 510(k) clearance record for CAMERA COVER WITH TEAR TIP, a class I device, cleared for Hydro-Med Products, Inc. on under FDA product code FEM (Accessories, Photographic, For Endoscope (Exclude Light Sources)). FDA records list 13 510(k) clearances for Hydro-Med Products, Inc., from to . As of , FDA records show no recalls naming K940152.

Clearance record

Decision date
Received
(298 days to decision)
Product code
FEM Accessories, Photographic, For Endoscope (Exclude Light Sources)
Regulation
21 CFR 876.1500
Device class
Class I
Review panel
Gastroenterology, Urology
Applicant
Hydro-Med Products, Inc. 2930 Ladybird Ln., Dallas TX
510(k) summary
Summary
Third party review
No

Clearances, product code FEM

Trailing 12 months

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

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