510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K993089Substantially Equivalent

Deroyal Disposable Rigid Light Handle and Adapter

Deroyal Cardiovascular, Inc., Powell TN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K993089 is the FDA 510(k) clearance record for DEROYAL DISPOSABLE RIGID LIGHT HANDLE AND ADAPTER, a class II device, cleared for Deroyal Cardiovascular, Inc. on under FDA product code FTA (Light, Surgical, Accessories). FDA records list one 510(k) clearance for Deroyal Cardiovascular, Inc. As of , FDA records show no recalls naming K993089.

Clearance record

Decision date
Received
(28 days to decision)
Product code
FTA Light, Surgical, Accessories
Regulation
21 CFR 878.4580
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Deroyal Cardiovascular, Inc. 200 Debusk Ln., Powell TN
510(k) summary
Summary
Third party review
No

Clearances, product code FTA

Trailing 12 months

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

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