STONE DISLODGER— 510(k) K800608

Name: FDA 510(k) clearance K800608
Creator: U.S. Food and Drug Administration
Published: 1980-04-08

Substantially Equivalent

G.D. Searle and Co.

FDA 510(k) clearance K800608 for STONE DISLODGER, Substantially Equivalent on 1980-04-08. Applicant: G.D. Searle and Co.. Device class: 2.

Clearance details

Applicant: G.D. Searle and Co.
Product code: Code FFL
Device class: Class 2
Regulation: 21 CFR 876.4680
Advisory panel: Gastroenterology, Urology
Date received: 1980-03-17
Decision date: 1980-04-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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K052048 — ACCORDION2005-09-13

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K811071 — VENOUS OXYGEN PROBE1981-05-05
K803238 — INTRAVASCULAR CATHETER1981-04-23
K810630 — SILICONE ELASTOMER COATED LATEX FOLEY1981-03-31

Adverse events under product code FFL

product code FFL

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 →

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