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FDA 510(k)

EXTRAHAND BALLOON RETRACTOR

K-Number: K962005 · 1996-08-12

ApplicantOrigin Medsystems, Inc.
Decision Date1996-08-12
Product CodeGCJ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

EXTRAHAND BALLOON RETRACTOR is the device name listed in this FDA 510(k) record. The listed applicant is Origin Medsystems, Inc.. It received FDA 510(k) clearance on 1996-08-12 under 510(k) number K962005. 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 EXTRAHAND BALLOON RETRACTOR?

EXTRAHAND BALLOON RETRACTOR is a medical device that received FDA 510(k) clearance on 1996-08-12. The listed applicant is Origin Medsystems, Inc.. The 510(k) number is K962005.

When did EXTRAHAND BALLOON RETRACTOR receive FDA 510(k) clearance?

EXTRAHAND BALLOON RETRACTOR received FDA 510(k) clearance on 1996-08-12, under 510(k) number K962005.

Who is the listed applicant for EXTRAHAND BALLOON RETRACTOR?

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

What is the FDA product code for EXTRAHAND BALLOON RETRACTOR?

The FDA product code for EXTRAHAND BALLOON RETRACTOR 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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