510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K043494Substantially Equivalent

Mastel Laser Clean Room, Model Ebs-100

Mastel Precision Surgical Instruments, Inc., Rapid City SD / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K043494 is the FDA 510(k) clearance record for MASTEL LASER CLEAN ROOM, MODEL EBS-100, a class II device, cleared for Mastel Precision Surgical Instruments, Inc. on under FDA product code FYD (Apparatus, Exhaust, Surgical). FDA records list one 510(k) clearance for Mastel Precision Surgical Instruments, Inc. As of , FDA records show no recalls naming K043494.

Clearance record

Decision date
Received
(291 days to decision)
Product code
FYD Apparatus, Exhaust, Surgical
Regulation
21 CFR 878.5070
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Mastel Precision Surgical Instruments, Inc. 2843 Samco Rd., Suite A, Rapid City SD
510(k) summary
Summary PDF
Third party review
No

Clearances, product code FYD

Trailing 12 months

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

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