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FDA 510(k)

ELLIPTI-PUNCH

K-Number: K854159 · 1985-11-15

ApplicantAlcon Laboratories
Decision Date1985-11-15
Product CodeFZI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

ELLIPTI-PUNCH is the device name listed in this FDA 510(k) record. The listed applicant is Alcon Laboratories. It received FDA 510(k) clearance on 1985-11-15 under 510(k) number K854159. The device is classified under product code FZI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ELLIPTI-PUNCH?

ELLIPTI-PUNCH is a medical device that received FDA 510(k) clearance on 1985-11-15. The listed applicant is Alcon Laboratories. The 510(k) number is K854159.

When did ELLIPTI-PUNCH receive FDA 510(k) clearance?

ELLIPTI-PUNCH received FDA 510(k) clearance on 1985-11-15, under 510(k) number K854159.

Who is the listed applicant for ELLIPTI-PUNCH?

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

What is the FDA product code for ELLIPTI-PUNCH?

The FDA product code for ELLIPTI-PUNCH is FZI.

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Other records listing Alcon Laboratories 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: FZI)

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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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