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FDA 510(k)

UNIVERSAL COUPLER, LAPAROSCOPIC ACCESSORY

K-Number: K912247 · 1991-11-13

ApplicantLaser Engineering, Inc.
Decision Date1991-11-13
Product CodeGCJ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

UNIVERSAL COUPLER, LAPAROSCOPIC ACCESSORY 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 1991-11-13 under 510(k) number K912247. The device is classified under product code GCJ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the UNIVERSAL COUPLER, LAPAROSCOPIC ACCESSORY?

UNIVERSAL COUPLER, LAPAROSCOPIC ACCESSORY is a medical device that received FDA 510(k) clearance on 1991-11-13. The listed applicant is Laser Engineering, Inc.. The 510(k) number is K912247.

When did UNIVERSAL COUPLER, LAPAROSCOPIC ACCESSORY receive FDA 510(k) clearance?

UNIVERSAL COUPLER, LAPAROSCOPIC ACCESSORY received FDA 510(k) clearance on 1991-11-13, under 510(k) number K912247.

Who is the listed applicant for UNIVERSAL COUPLER, LAPAROSCOPIC ACCESSORY?

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 UNIVERSAL COUPLER, LAPAROSCOPIC ACCESSORY?

The FDA product code for UNIVERSAL COUPLER, LAPAROSCOPIC ACCESSORY is GCJ.

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Other records listing Laser Engineering, 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.

K211605Dual SwitchK924457MICROMANIPULATORK912347BIPURE 1000K91006202-10,001K911852COMPULSE CO2 SURGICAL LASER SYS.K905676MD CO2 SURGICAL LASER SYSTEM/GEN. SURGERY AND ORTH

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Related Devices (Code: GCJ)

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

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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