METAL URETERAL BASKET STONE DISLODGER— 510(k) K896992

Clearance details

Applicant

Annex Medical, Inc.

Product code

Code FFL

Device class

Class 2

Regulation

21 CFR 876.4680

Advisory panel

Gastroenterology, Urology

Date received

1989-12-11

Decision date

1990-02-08

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Eden Prairie, MN, US

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• K052048 — ACCORDION2005-09-13

• K954377 — FORCEPS, GRASPING, FLEXIBLE ENDOSCOPIC1995-10-26
• K951532 — METAL URETERAL BASKET STONE DISLODGER1995-07-19
• K952863 — FORCEPS, BIOPSY, NON-ELECTRIC1995-07-19
• K951761 — METEL URETERAL BASKET STONE DISLODGER1995-05-11
• K934636 — ANNEX MEDICAL FLAT WIRE STONE EXTRACTOR1994-02-25

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 →