510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K843627Substantially Equivalent

Venesection Tray, Adult 6050

Pro-Lab, Inc., Round Rock TX / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K843627 is the FDA 510(k) clearance record for VENESECTION TRAY, ADULT 6050, a class I device, cleared for Pro-Lab, Inc. on under FDA product code FSM (Tray, Surgical, Instrument). FDA records list 27 510(k) clearances for Pro-Lab, Inc., from to . As of , FDA records show no recalls naming K843627.

Clearance record

Decision date
Received
(81 days to decision)
Product code
FSM Tray, Surgical, Instrument
Regulation
21 CFR 878.4800
Device class
Class I
Review panel
General, Plastic Surgery
Applicant
Pro-Lab, Inc. P.O. Box 503, Round Rock TX
Third party review
No

Clearances, product code FSM

Trailing 12 months

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

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