SURGICAL DYNAMICS MENISCAL STAPLE— 510(k) K013890

Name: FDA 510(k) clearance K013890
Creator: U.S. Food and Drug Administration
Published: 2001-12-11

Substantially Equivalent

United States Surgical, A Division of Tyco Healthc

FDA 510(k) clearance K013890 for SURGICAL DYNAMICS MENISCAL STAPLE, Substantially Equivalent on 2001-12-11. 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: Product code HWC
Device class: Class 2
Regulation: 21 CFR 888.3040
Advisory panel: Orthopedic
Date received: 2001-11-23
Decision date: 2001-12-11
Decision: Substantially Equivalent
Clearance type: Special
Location: Norwalk, CT, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code HWC

view all

K263116 — OsteoCentric Technologies Cannulated and Soild Fasteners with Nuts2026-10-02
K262975 — Arthrex Beaming System2026-09-25
K260995 — DynaNail Helix® Fixation System2026-09-23
K254280 — F.A.S.T Screw2026-09-21
K261057 — ActivaScrew Cannulated COM2026-09-04

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 HWC

product code HWC

Death: 20
Injury: 15,910
Malfunction: 8,192
Other: 1
Total: 24,123

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.