510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K082803Substantially Equivalent

Coaxial Accordion Stone Management Device, Model: Coac12005 - Coa20015

Percutaneous Systems, Inc., Palo Alto CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K082803 is the FDA 510(k) clearance record for COAXIAL ACCORDION STONE MANAGEMENT DEVICE, MODEL: COAC12005 - COA20015, a class II device, cleared for Percutaneous Systems, Inc. on under FDA product code FFL (Dislodger, Stone, Basket, Ureteral, Metal). FDA records list 6 510(k) clearances for Percutaneous Systems, Inc., from to . As of , FDA records show no recalls naming K082803.

Clearance record

Decision date
Received
(50 days to decision)
Product code
FFL Dislodger, Stone, Basket, Ureteral, Metal
Regulation
21 CFR 876.4680
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Percutaneous Systems, Inc. 3260 Hill View Ave., Palo Alto CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code FFL

Trailing 12 months

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

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