AUTO SUTURE* MODIFIED ENDOSCOPIC FASCIA STAPLER** DEVICE— 510(k) K963999

Name: FDA 510(k) clearance K963999
Creator: U.S. Food and Drug Administration
Published: 1996-11-27

Substantially Equivalent

United States Surgical, A Division of Tyco Healthc

FDA 510(k) clearance K963999 for AUTO SUTURE* MODIFIED ENDOSCOPIC FASCIA STAPLER** DEVICE, Substantially Equivalent on 1996-11-27. 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 OCW
Device class: Class 2
Regulation: 21 CFR 876.1500
Advisory panel: Gastroenterology, Urology
Date received: 1996-10-07
Decision date: 1996-11-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Norwalk, CT, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code OCW

view all

K252400 — Endomina EZFuse system2026-02-13
K243750 — SimpleStitch Suturing System2025-04-17
K231240 — MaxTack Motorized Fixation Device2023-09-08
K213271 — MedicloseTM System2023-08-31
K231553 — OverStitch NXT Endoscopic Suturing System2023-06-29

More clearances from United States Surgical, A Division of Tyco Healthc

view all

K071406 — AUTOSUTURE ENDO CLIP III 5 MM CLIP APPLIER2007-11-21
K071920 — AUTOSUTURE ABSORBABLE TACK AND APPLICATOR2007-09-28
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 OCW

product code OCW

Death: 6
Injury: 443
Malfunction: 1,023
Other: 2
Total: 1,474

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.