510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K980915Substantially Equivalent

Valleylab Optimumm Smoke Evacuator System

Medtronic, Inc., Boulder CO / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K980915 is the FDA 510(k) clearance record for VALLEYLAB OPTIMUMM SMOKE EVACUATOR SYSTEM, a class II device, cleared for Valleylab, Inc. on under FDA product code FYD (Apparatus, Exhaust, Surgical). FDA records list 1,525 510(k) clearances for Medtronic, Inc., from to . As of , FDA records show no recalls naming K980915.

Clearance record

Decision date
Received
(110 days to decision)
Product code
FYD Apparatus, Exhaust, Surgical
Regulation
21 CFR 878.5070
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Valleylab, Inc. 5920 Longbow Dr., Boulder CO
510(k) summary
Summary
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 November 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code FYD, trailing twelve months
MonthClearances
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260
November 20260