510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K933181Substantially Equivalent

Valleylab Force Gsu Handset Adapter Model #E0500

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

K933181 is the FDA 510(k) clearance record for VALLEYLAB FORCE GSU HANDSET ADAPTER MODEL #E0500, a class I device, cleared for Valleylab, Inc. on under FDA product code GFI (Osteotome, Manual). FDA records list 1,525 510(k) clearances for Medtronic, Inc., from to . As of , FDA records show no recalls naming K933181.

Clearance record

Decision date
Received
(125 days to decision)
Product code
GFI Osteotome, Manual
Regulation
21 CFR 878.4800
Device class
Class I
Review panel
General, Plastic Surgery
Applicant
Valleylab, Inc. 5920 Longbow Dr., Boulder CO
510(k) summary
Summary
Third party review
No

Clearances, product code GFI

Trailing 12 months

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

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