ULTRASONIC HAND INSTRUMENTS— 510(k) K971861

Name: FDA 510(k) clearance K971861
Creator: U.S. Food and Drug Administration
Published: 1997-07-01

Substantially Equivalent

United States Surgical, A Division of Tyco Healthc

FDA 510(k) clearance K971861 for ULTRASONIC HAND INSTRUMENTS, Substantially Equivalent on 1997-07-01. Applicant: United States Surgical, A Division of Tyco Healthc. Device class: Unclassified.

Clearance details

Applicant: United States Surgical, A Division of Tyco Healthc
Product code: Code LFL
Device class: Unclassified
Advisory panel: Unknown
Date received: 1997-05-20
Decision date: 1997-07-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Norwalk, CT, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code LFL

view all

K261448 — neXus Ultrasonic Surgical Aspirator System2026-07-30
K251162 — CUSA® Clarity Ultrasonic Surgical Aspirator System2025-10-08
K242894 — SanAgile Ultrasonic Surgery Advanced Portable Controller (SA10) +4 more2025-06-18
K243930 — Sonopet iQ Ultrasonic Aspirator System (5500-050-000)2025-03-24
K241700 — Tenex 2nd Generation System2024-11-18

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 LFL

product code LFL

Death: 29
Injury: 1,046
Malfunction: 21,642
Total: 22,717

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.