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FDA 510(k)

ENDOSCOPE INTRODUCER KIT

K-Number: K955717 · 1996-04-18

ApplicantMitsubishi Cable America, Inc.
Decision Date1996-04-18
Product CodeFDE
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

ENDOSCOPE INTRODUCER KIT is the device name listed in this FDA 510(k) record. The listed applicant is Mitsubishi Cable America, Inc.. It received FDA 510(k) clearance on 1996-04-18 under 510(k) number K955717. The device is classified under product code FDE. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ENDOSCOPE INTRODUCER KIT?

ENDOSCOPE INTRODUCER KIT is a medical device that received FDA 510(k) clearance on 1996-04-18. The listed applicant is Mitsubishi Cable America, Inc.. The 510(k) number is K955717.

When did ENDOSCOPE INTRODUCER KIT receive FDA 510(k) clearance?

ENDOSCOPE INTRODUCER KIT received FDA 510(k) clearance on 1996-04-18, under 510(k) number K955717.

Who is the listed applicant for ENDOSCOPE INTRODUCER KIT?

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

What is the FDA product code for ENDOSCOPE INTRODUCER KIT?

The FDA product code for ENDOSCOPE INTRODUCER KIT is FDE.

Related Clinical Trials

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Other records listing Mitsubishi Cable America, 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.

K960081BATTERY POWERED ENDOSCCOPIC LIGHT SOURCEK936257ULTRATHIN FLEXIBLE ENDOSCOPE TAS-211/2.3

Related Devices (Code: FDE)

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.

K950924ASLAN KNOT PUSHERAslan Medical Technologies, Ltd.K942677GEENEN/ZEBRA GUIDELINESBoston Scientific CorpK912443CANDELA INTRODUCER SHEATH SYSTEMCandela Laser Corp.

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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