SURGITEK ALL SILICONE INFECTION DOUBJ— 510(k) K833782

Name: FDA 510(k) clearance K833782
Creator: U.S. Food and Drug Administration
Published: 1984-04-02

Substantially Equivalent

Surgitek

FDA 510(k) clearance K833782 for SURGITEK ALL SILICONE INFECTION DOUBJ, Substantially Equivalent on 1984-04-02. Applicant: Surgitek. Device class: 2.

Clearance details

Applicant: Surgitek
Product code: Code FAD
Device class: Class 2
Regulation: 21 CFR 876.4620
Advisory panel: Gastroenterology, Urology
Date received: 1983-10-28
Decision date: 1984-04-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code FAD

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K251890 — Disposable Ureteral Stents2026-02-20
K251469 — Endura Ureteral Stent and Stent Set2025-12-19
K243039 — Ureteral Stents (AF-D series)2025-06-18
K243830 — Disposable ureteral stent2025-05-14
K250824 — Percuflex Ureteral Stent +11 more2025-04-15

More clearances from Surgitek

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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
K933260 — HELICAL STONE/FLATWIRE STONE BASKETS1994-01-11

Adverse events under product code FAD

product code FAD

Death: 2
Injury: 858
Malfunction: 2,651
Other: 1
Total: 3,512

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.