FLEXIBLE SNARE— 510(k) K902265

Name: FDA 510(k) clearance K902265
Creator: U.S. Food and Drug Administration
Published: 1990-07-27

Substantially Equivalent

Annex Medical, Inc.

FDA 510(k) clearance K902265 for FLEXIBLE SNARE, Substantially Equivalent on 1990-07-27. Applicant: Annex Medical, Inc.. Device class: 2.

Clearance details

Applicant: Annex Medical, Inc.
Product code: Code FDI
Device class: Class 2
Regulation: 21 CFR 876.4300
Advisory panel: Gastroenterology, Urology
Date received: 1990-05-21
Decision date: 1990-07-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Eden Prairie, MN, US

Download summary PDF View on FDA.gov ↗

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More clearances from Annex Medical, Inc.

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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

Adverse events under product code FDI

product code FDI

Death: 6
Injury: 217
Malfunction: 1,544
Total: 1,767

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 →

Data sourced from openFDA. This site is unofficial and independent of the FDA.