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FDA 510(k)

BIPURE 1000

K-Number: K912347 · 1991-09-23

ApplicantLaser Engineering, Inc.
Decision Date1991-09-23
Product CodeFYD
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

BIPURE 1000 is the device name listed in this FDA 510(k) record. The listed applicant is Laser Engineering, Inc.. It received FDA 510(k) clearance on 1991-09-23 under 510(k) number K912347. The device is classified under product code FYD. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BIPURE 1000?

BIPURE 1000 is a medical device that received FDA 510(k) clearance on 1991-09-23. The listed applicant is Laser Engineering, Inc.. The 510(k) number is K912347.

When did BIPURE 1000 receive FDA 510(k) clearance?

BIPURE 1000 received FDA 510(k) clearance on 1991-09-23, under 510(k) number K912347.

Who is the listed applicant for BIPURE 1000?

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

What is the FDA product code for BIPURE 1000?

The FDA product code for BIPURE 1000 is FYD.

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Other records listing Laser Engineering, Inc. as applicant

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K211605Dual SwitchK924457MICROMANIPULATORK912247UNIVERSAL COUPLER, LAPAROSCOPIC ACCESSORYK91006202-10,001K911852COMPULSE CO2 SURGICAL LASER SYS.K905676MD CO2 SURGICAL LASER SYSTEM/GEN. SURGERY AND ORTH

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Related Devices (Code: FYD)

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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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