SOFT TISSUE ANCHORING SET KIT— 510(k) K874439

Name: FDA 510(k) clearance K874439
Creator: U.S. Food and Drug Administration
Published: 1987-11-20

Substantially Equivalent

Concept, Inc.

FDA 510(k) clearance K874439 for SOFT TISSUE ANCHORING SET KIT, Substantially Equivalent on 1987-11-20. Applicant: Concept, Inc.. Device class: 2.

Clearance details

Applicant: Concept, Inc.
Product code: Code LRO
Device class: Class 2
Regulation: 21 CFR 878.4370
Advisory panel: General, Plastic Surgery
Date received: 1987-10-28
Decision date: 1987-11-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Clearwater, FL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code LRO

view all

K213481 — Medline General Surgery Tray2022-05-24
K212258 — Medline Cardiovascular Procedure Kit2021-12-03
K041080 — SURGICAL DRAPE KIT - D.I.R.R.A. SRL2004-11-30
K030721 — QUICK-TAP PARACENTESIS TRAY, KIT & NEEDLE2003-03-31
K023276 — AMSINO TRACHEOSTOMY CARE TRAY2002-12-09

More clearances from Concept, Inc.

view all

K912640 — CONCEPT ENDOSTEAL FIXATION DEVICE1992-05-01
K912957 — CONCEPT MICROMILL1991-10-04
K896648 — CONCEPT UNICOMPARTMENTAL KNEE SYSTEM1990-06-05
K894929 — STAPLE FIXATION SYSTEM1989-08-30
K892376 — INTRAVISION(TM) ARTHROSCOPE SYSTEM (ADD'L APPLI.)1989-08-01

Adverse events under product code LRO

product code LRO

Injury: 975
Malfunction: 14,038
Other: 2
Total: 15,015

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.