KEY COMFORT GRIPS— 510(k) K910328

Name: FDA 510(k) clearance K910328
Creator: U.S. Food and Drug Administration
Published: 1991-03-06

Substantially Equivalent

Key Surgical, Inc.

FDA 510(k) clearance K910328 for KEY COMFORT GRIPS, Substantially Equivalent on 1991-03-06. Applicant: Key Surgical, Inc.. Device class: 1.

Clearance details

Applicant: Key Surgical, Inc.
Product code: Code FSM
Device class: Class 1
Regulation: 21 CFR 878.4800
Advisory panel: General, Plastic Surgery
Date received: 1991-01-25
Decision date: 1991-03-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Minneapolis, MN, US

Download summary PDF View on FDA.gov ↗

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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

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K150532 — Universal Light Handle Cover, Light Handle Cover2015-09-22
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K896676 — KEY VASCULAR LOOPS1990-02-27
K896472 — KEY VASCULAR BOOTIES1989-12-14
K895591 — SILICONE INSTRUMENT SHODS1989-10-20

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.