510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K120473Substantially Equivalent

Pixel App

Gauss Surgical, Inc., Cupertino CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K120473 is the FDA 510(k) clearance record for PIXEL APP, a class I device, cleared for Gauss Surgical, Inc., on under FDA product code LWH (Counter, Sponge, Surgical). FDA records list 6 510(k) clearances for Gauss Surgical, Inc.,, from to . As of , FDA records show no recalls naming K120473.

Clearance record

Decision date
Received
(53 days to decision)
Product code
LWH Counter, Sponge, Surgical
Regulation
21 CFR 880.2740
Device class
Class I
Review panel
General Hospital
Applicant
Gauss Surgical, Inc., 22700 Alcalde Rd., Cupertino CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code LWH

Trailing 12 months

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

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