GENERAL PURPOSE INSTRUMENT TRAYS SUTURE REMOVAL TR— 510(k) K844613

Name: FDA 510(k) clearance K844613
Creator: U.S. Food and Drug Administration
Published: 1985-01-10

Substantially Equivalent

Packaging Technologies, Inc.

FDA 510(k) clearance K844613 for GENERAL PURPOSE INSTRUMENT TRAYS SUTURE REMOVAL TR, Substantially Equivalent on 1985-01-10. Applicant: Packaging Technologies, Inc.. Device class: 1.

Clearance details

Applicant: Packaging Technologies, Inc.
Product code: Code FSM
Device class: Class 1
Regulation: 21 CFR 878.4800
Advisory panel: General, Plastic Surgery
Date received: 1984-11-27
Decision date: 1985-01-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Brea, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code FSM

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K971217 — INSTRUMENT TRAY LINER1997-05-06
K962328 — SINGLE USE INSTRUMENT TRAY1996-08-09
K944025 — SURGICAL INSTRUMENT TRAY1994-11-22
K912106 — ARTHROSCOPY TRAY1991-08-29
K912053 — OPEN HEART TRAY1991-08-26

More clearances from Packaging Technologies, Inc.

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K881756 — STERILE SURGEONS GLOVES1988-06-01
K863326 — BONE MARROW TRAY1986-09-16
K861041 — ENHANCE1986-05-30
K850544 — SHAVE PREP TRAY1985-03-12
K850438 — RENAL BIOPSY TRAY1985-02-26

Adverse events under product code FSM

product code FSM

Malfunction: 1,289
Total: 1,289

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.