SUTURE RACK & NEEDLE COUNTER— 510(k) K760428

Name: FDA 510(k) clearance K760428
Creator: U.S. Food and Drug Administration
Published: 1976-11-02

Substantially Equivalent

Kleen Test Products

FDA 510(k) clearance K760428 for SUTURE RACK & NEEDLE COUNTER, Substantially Equivalent on 1976-11-02. Applicant: Kleen Test Products. Device class: 1.

Clearance details

Applicant: Kleen Test Products
Product code: Code FSM
Device class: Class 1
Regulation: 21 CFR 878.4800
Advisory panel: General, Plastic Surgery
Date received: 1976-08-13
Decision date: 1976-11-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, 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 Kleen Test Products

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K890039 — KLEEN TEST BASIN SET1989-10-24
K890539 — SURE COUNT LIGHT HANDLE COVER1989-02-27
K890098 — KLEEN TEST O.R. KIT1989-01-24
K853622 — SURE COUNT 30 COUNT FOAM & MAGNETIC 92-30301985-10-10
K853454 — SURE COUNT 5 & 10 SPONGE COUNTER1985-09-05

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.