ANKLE HOLDER W/ANKLE SUPPORT KIT FOR LEG HOLDER— 510(k) K865024

Name: FDA 510(k) clearance K865024
Creator: U.S. Food and Drug Administration
Published: 1987-01-12

Substantially Equivalent

American Container Technology, Inc.

FDA 510(k) clearance K865024 for ANKLE HOLDER W/ANKLE SUPPORT KIT FOR LEG HOLDER, Substantially Equivalent on 1987-01-12. Applicant: American Container Technology, Inc.. Device class: 1.

Clearance details

Applicant: American Container Technology, Inc.
Product code: Code FWZ
Device class: Class 1
Regulation: 21 CFR 878.4950
Advisory panel: General, Plastic Surgery
Date received: 1986-12-23
Decision date: 1987-01-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Wallington, NJ, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code FWZ

view all

K960019 — RETRACTOR ARM CLAMP1996-02-09
K945415 — 'LIL MAC ACCESSORY CLAMP(TM)1994-11-22
K944779 — CARBON LIGHTS HAND SURGERY TABLE1994-10-14
K935381 — KAPS POSITIONING ARM1994-04-15
K931037 — WHITMORE VACUUM-LOCK SPINAL FRAME (VLSF-100)1993-07-30

More clearances from American Container Technology, Inc.

view all

K864476 — LEG HOLDER1986-12-15
K864459 — RAIL CLAMP EXTENSION PIECE1986-12-01

Adverse events under product code FWZ

product code FWZ

Malfunction: 932
Other: 1
Total: 933

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.