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FDA 510(k)

ENDOSCOPIC ACCESSORY

K-Number: K945191 · 1995-05-03

ApplicantUn-I-Med, Inc.
Decision Date1995-05-03
Product CodeFAS
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

ENDOSCOPIC ACCESSORY is the device name listed in this FDA 510(k) record. The listed applicant is Un-I-Med, Inc.. It received FDA 510(k) clearance on 1995-05-03 under 510(k) number K945191. The device is classified under product code FAS. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ENDOSCOPIC ACCESSORY?

ENDOSCOPIC ACCESSORY is a medical device that received FDA 510(k) clearance on 1995-05-03. The listed applicant is Un-I-Med, Inc.. The 510(k) number is K945191.

When did ENDOSCOPIC ACCESSORY receive FDA 510(k) clearance?

ENDOSCOPIC ACCESSORY received FDA 510(k) clearance on 1995-05-03, under 510(k) number K945191.

Who is the listed applicant for ENDOSCOPIC ACCESSORY?

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

What is the FDA product code for ENDOSCOPIC ACCESSORY?

The FDA product code for ENDOSCOPIC ACCESSORY is FAS.

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Other records listing Un-I-Med, 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.

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Related Devices (Code: FAS)

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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Official Source

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