510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K163507Substantially Equivalent

Triton Sponge System

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

K163507 is the FDA 510(k) clearance record for Triton Sponge System, a class II device, cleared for Gauss Surgical, Inc., on under FDA product code PBZ (Image Processing Device For Estimation Of External Blood Loss). FDA's definition for product code PBZ reads: "An image processing device for estimation of external blood loss is a device to be used as an aid in estimation of patient external blood loss. The device may include software and/or hardware that is used to process images capturing...". FDA records list 6 510(k) clearances for Gauss Surgical, Inc.,, from to . As of , FDA records show no recalls naming K163507.

Clearance record

Decision date
Received
(132 days to decision)
Product code
PBZ Image Processing Device For Estimation Of External Blood Loss
Regulation
21 CFR 880.2750
Device class
Class II
Review panel
General Hospital
Applicant
Gauss Surgical, Inc., 334 State St., Suite 201, Los Altos CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code PBZ

Trailing 12 months
1 clearance under product code PBZ in the twelve months to October 2026, March 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code PBZ, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20261
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260