COAXIAL ACCORDION STONE MANAGEMENT DEVICE, MODEL: COAC12005 - COA20015— 510(k) K082803

Clearance details

Applicant

Percutaneous Systems, Inc.

Product code

Code FFL

Device class

Class 2

Regulation

21 CFR 876.4680

Advisory panel

Gastroenterology, Urology

Date received

2008-09-24

Decision date

2008-11-13

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Palo Alto, CA, US

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• K102887 — ACCORDION STONE MANAGEMENT DEVICE MODEL AC281205 AND AC38145102011-05-16
• K052048 — ACCORDION2005-09-13
• K012581 — REPROCESSED STONE RETRIEVAL BASKETS2002-02-14

• K052134 — CYSTOGLIDE DILATING INTRODUCER SHEATH2005-09-22
• K042877 — MICROVERTER URETERAL ACCESS SHEATH2004-11-16
• K040519 — SLIP UROLOGY CATHETER2004-05-20
• K040520 — SLIP UROLOGY INTRODUCER SHEATH2004-05-20

Death

2

Injury

270

Malfunction

2,711

Other

2

Total

2,985

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →