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FDA 510(k)

ELAN-E DISPOSABLE DRAPE

K-Number: K884057 · 1988-10-19

ApplicantAesculap Instruments Corp.
Decision Date1988-10-19
Product CodeKKX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

ELAN-E DISPOSABLE DRAPE is the device name listed in this FDA 510(k) record. The listed applicant is Aesculap Instruments Corp.. It received FDA 510(k) clearance on 1988-10-19 under 510(k) number K884057. The device is classified under product code KKX. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ELAN-E DISPOSABLE DRAPE?

ELAN-E DISPOSABLE DRAPE is a medical device that received FDA 510(k) clearance on 1988-10-19. The listed applicant is Aesculap Instruments Corp.. The 510(k) number is K884057.

When did ELAN-E DISPOSABLE DRAPE receive FDA 510(k) clearance?

ELAN-E DISPOSABLE DRAPE received FDA 510(k) clearance on 1988-10-19, under 510(k) number K884057.

Who is the listed applicant for ELAN-E DISPOSABLE DRAPE?

The FDA 510(k) record lists Aesculap Instruments Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ELAN-E DISPOSABLE DRAPE?

The FDA product code for ELAN-E DISPOSABLE DRAPE is KKX.

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Other records listing Aesculap Instruments Corp. 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: KKX)

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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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