SUTURE CLIP REMOVER— 510(k) K771640

Name: FDA 510(k) clearance K771640
Creator: U.S. Food and Drug Administration
Published: 1977-09-30

Substantially Equivalent

United States Surgical, A Division of Tyco Healthc

FDA 510(k) clearance K771640 for SUTURE CLIP REMOVER, Substantially Equivalent on 1977-09-30. Applicant: United States Surgical, A Division of Tyco Healthc. Device class: 1.

Clearance details

Applicant: United States Surgical, A Division of Tyco Healthc
Product code: Code GDO
Device class: Class 1
Regulation: 21 CFR 878.4800
Advisory panel: General, Plastic Surgery
Date received: 1977-08-29
Decision date: 1977-09-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code GDO

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K926199 — UNICLIP SURGICAL CLIP APPLIER1993-04-20
K890941 — MODIFIED SUTURE DISP. ENDOSCOPIC SURGICAL CLIP APP1989-04-07
K890159 — TOWEL CLIPS1989-02-03
K890233 — SUTURE CLIP APPLIER/REMOVER1989-01-27
K820837 — DISPOSABLE MULTIPLE LIGATING CLIP1982-05-28

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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 GDO

product code GDO

Death: 5
Malfunction: 2,124
Total: 2,129

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.