SURGITEK DOUBLE J URETEROL STENT— 510(k) K781641

Name: FDA 510(k) clearance K781641
Creator: U.S. Food and Drug Administration
Published: 1978-12-07

Substantially Equivalent

Medical Engineering Corp.

FDA 510(k) clearance K781641 for SURGITEK DOUBLE J URETEROL STENT, Substantially Equivalent on 1978-12-07. Applicant: Medical Engineering Corp.. Device class: 2.

Clearance details

Applicant: Medical Engineering Corp.
Product code: Code FAD
Device class: Class 2
Regulation: 21 CFR 876.4620
Advisory panel: Gastroenterology, Urology
Date received: 1978-09-21
Decision date: 1978-12-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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K934141 — STAND ALONE CYSTOMETROGRAM1993-11-18
K905289 — SURGITEK(R) LUBRI-FLEX(TM) URETERAL STENT1991-03-13
K903448 — SURGITEK TEX-SPAN TEXTURED TISSUE EXPANDER1991-01-14
K902773 — SURGITEK(R) FLEXIBLE URETEROSCOPY INTRO/SHEATH SET1990-07-16
K884746 — SURGITEK FLAT T-SPAN1989-08-10

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.