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FDA 510(k)

INNOVASIVE NON-STERILE LAPAROSCOPY INSTRUMENTS MODIFICATION

K-Number: K934338 · 1994-02-10

ApplicantInnovasive Devices, Inc.
Decision Date1994-02-10
Product CodeGCJ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

INNOVASIVE NON-STERILE LAPAROSCOPY INSTRUMENTS MODIFICATION is the device name listed in this FDA 510(k) record. The listed applicant is Innovasive Devices, Inc.. It received FDA 510(k) clearance on 1994-02-10 under 510(k) number K934338. The device is classified under product code GCJ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the INNOVASIVE NON-STERILE LAPAROSCOPY INSTRUMENTS MODIFICATION?

INNOVASIVE NON-STERILE LAPAROSCOPY INSTRUMENTS MODIFICATION is a medical device that received FDA 510(k) clearance on 1994-02-10. The listed applicant is Innovasive Devices, Inc.. The 510(k) number is K934338.

When did INNOVASIVE NON-STERILE LAPAROSCOPY INSTRUMENTS MODIFICATION receive FDA 510(k) clearance?

INNOVASIVE NON-STERILE LAPAROSCOPY INSTRUMENTS MODIFICATION received FDA 510(k) clearance on 1994-02-10, under 510(k) number K934338.

Who is the listed applicant for INNOVASIVE NON-STERILE LAPAROSCOPY INSTRUMENTS MODIFICATION?

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

What is the FDA product code for INNOVASIVE NON-STERILE LAPAROSCOPY INSTRUMENTS MODIFICATION?

The FDA product code for INNOVASIVE NON-STERILE LAPAROSCOPY INSTRUMENTS MODIFICATION is GCJ.

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Related Devices (Code: GCJ)

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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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