510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K902000Substantially Equivalent

Kevtek(tm) Laser Drape/organ Protector/eye Shield

Kevtek Medical Products, Inc., Houston TX / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K902000 is the FDA 510(k) clearance record for KEVTEK(TM) LASER DRAPE/ORGAN PROTECTOR/EYE SHIELD, a class I device, cleared for Kevtek Medical Products, Inc. on under FDA product code FZS (Curette, Surgical, General Use). FDA records list 2 510(k) clearances for Kevtek Medical Products, Inc., from to . As of , FDA records show no recalls naming K902000.

Clearance record

Decision date
Received
(111 days to decision)
Product code
FZS Curette, Surgical, General Use
Regulation
21 CFR 878.4800
Device class
Class I
Review panel
General, Plastic Surgery
Applicant
Kevtek Medical Products, Inc. P.O. Box 580644, Houston TX
Third party review
No

Clearances, product code FZS

Trailing 12 months

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

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