AUTO SUTURE SURGIPORT DEPTH GUIDE AND SKIRT— 510(k) K893707

Name: FDA 510(k) clearance K893707
Creator: U.S. Food and Drug Administration
Published: 1989-06-15

Substantially Equivalent

United States Surgical, A Division of Tyco Healthc

FDA 510(k) clearance K893707 for AUTO SUTURE SURGIPORT DEPTH GUIDE AND SKIRT, Substantially Equivalent on 1989-06-15. Applicant: United States Surgical, A Division of Tyco Healthc. Device class: 2.

Clearance details

Applicant: United States Surgical, A Division of Tyco Healthc
Product code: Code DRC
Device class: Class 2
Regulation: 21 CFR 870.1390
Advisory panel: Cardiovascular
Date received: 1989-05-18
Decision date: 1989-06-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Norwalk, CT, US

Download summary PDF View on FDA.gov ↗

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K061288 — AUTO SUTURE ENDO CLIP III 5 MM CLIP APPLIER2006-11-02
K062850 — AUTOSUTURE CIRCULAR EEA SURGICAL STAPLERS2006-10-23
K062326 — AUTOSUTURE MODIFIED VERSAPORT TROCAR WITH FIXATION SLEEVE2006-09-01

Adverse events under product code DRC

product code DRC

Death: 28
Injury: 412
Total: 440

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.