TISSUE EXPANDER— 510(k) K840464

Name: FDA 510(k) clearance K840464
Creator: U.S. Food and Drug Administration
Published: 1984-03-12

Substantially Equivalent

Surgitek

FDA 510(k) clearance K840464 for TISSUE EXPANDER, Substantially Equivalent on 1984-03-12. Applicant: Surgitek. Device class: Unclassified.

Clearance details

Applicant: Surgitek
Product code: Code LCJ
Device class: Unclassified
Advisory panel: Unknown
Date received: 1984-02-03
Decision date: 1984-03-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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K946296 — QUADRA-COIL URETERAL STENT1995-03-06
K944391 — OM-4 (TENATIVE) URODYNAMIC MEASRUEMENT SYSTEM1995-02-07
K943491 — RIGHT ANGLE UROLOGIC LASER FIBER1994-08-05
K941952 — SURGITEK INFUSER1994-05-24
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Adverse events under product code LCJ

product code LCJ

Injury: 2,704
Other: 2
Total: 2,706

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.