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FDA 510(k)

KEY COMFORT GRIPS

K-Number: K910328 · 1991-03-06

ApplicantKey Surgical, Inc.
Decision Date1991-03-06
Product CodeFSM
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

KEY COMFORT GRIPS is the device name listed in this FDA 510(k) record. The listed applicant is Key Surgical, Inc.. It received FDA 510(k) clearance on 1991-03-06 under 510(k) number K910328. The device is classified under product code FSM. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the KEY COMFORT GRIPS?

KEY COMFORT GRIPS is a medical device that received FDA 510(k) clearance on 1991-03-06. The listed applicant is Key Surgical, Inc.. The 510(k) number is K910328.

When did KEY COMFORT GRIPS receive FDA 510(k) clearance?

KEY COMFORT GRIPS received FDA 510(k) clearance on 1991-03-06, under 510(k) number K910328.

Who is the listed applicant for KEY COMFORT GRIPS?

The FDA 510(k) record lists Key Surgical, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for KEY COMFORT GRIPS?

The FDA product code for KEY COMFORT GRIPS is FSM.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Other records listing Key Surgical, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K896676KEY VASCULAR LOOPSK896472KEY VASCULAR BOOTIESK895591SILICONE INSTRUMENT SHODS

Related Devices (Code: FSM)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K971217INSTRUMENT TRAY LINERGeneral Hospital Supply Corp.K962328SINGLE USE INSTRUMENT TRAYMedcare Medical Group, Inc.K944025SURGICAL INSTRUMENT TRAYRiley Medical, Inc.K912106ARTHROSCOPY TRAYMedical Device Inspection Co., Inc.K912053OPEN HEART TRAYMedical Device Inspection Co., Inc.K912052HEART CATH TRAYMedical Device Inspection Co., Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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