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FDA 510(k)

INSTRA-SAFE

K-Number: K823430 · 1983-01-07

ApplicantInstranetics, Inc.
Decision Date1983-01-07
Product CodeFSM
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

INSTRA-SAFE is the device name listed in this FDA 510(k) record. The listed applicant is Instranetics, Inc.. It received FDA 510(k) clearance on 1983-01-07 under 510(k) number K823430. 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 INSTRA-SAFE?

INSTRA-SAFE is a medical device that received FDA 510(k) clearance on 1983-01-07. The listed applicant is Instranetics, Inc.. The 510(k) number is K823430.

When did INSTRA-SAFE receive FDA 510(k) clearance?

INSTRA-SAFE received FDA 510(k) clearance on 1983-01-07, under 510(k) number K823430.

Who is the listed applicant for INSTRA-SAFE?

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

What is the FDA product code for INSTRA-SAFE?

The FDA product code for INSTRA-SAFE 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 Instranetics, 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.

K811824CAUTERY CADDY PADK811823SHARPS CADDY FBK811822TIP-VUK810294LINE CADDYK810208BLADE SAFEK802865SAFE T COUNT

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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

View on FDA Database →

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

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