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FDA 510(k)

CO2 LASER MICROMANIPULATOR

K-Number: K864378 · 1987-03-05

ApplicantTransamerican Technologies Intl.
Decision Date1987-03-05
Product CodeHHR
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

CO2 LASER MICROMANIPULATOR is the device name listed in this FDA 510(k) record. The listed applicant is Transamerican Technologies Intl.. It received FDA 510(k) clearance on 1987-03-05 under 510(k) number K864378. The device is classified under product code HHR. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CO2 LASER MICROMANIPULATOR?

CO2 LASER MICROMANIPULATOR is a medical device that received FDA 510(k) clearance on 1987-03-05. The listed applicant is Transamerican Technologies Intl.. The 510(k) number is K864378.

When did CO2 LASER MICROMANIPULATOR receive FDA 510(k) clearance?

CO2 LASER MICROMANIPULATOR received FDA 510(k) clearance on 1987-03-05, under 510(k) number K864378.

Who is the listed applicant for CO2 LASER MICROMANIPULATOR?

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

What is the FDA product code for CO2 LASER MICROMANIPULATOR?

The FDA product code for CO2 LASER MICROMANIPULATOR is HHR.

Related Clinical Trials

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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Other records listing Transamerican Technologies Intl. 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.

K971677ACCU-SURG BI-POLAR ELECTRODES, L-HOOK, NEEDLE, BALL, BIPOLAR CORDK963193ACCU-BEAM LASER BLOCK 301513BG385/BEAM SPLITTERS 301513BG39K934398ACCU-BEAM TISSUE DRILL & ASPIRATION/INJECTION NEEDLE

Related Devices (Code: HHR)

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.

K881507ENDOCOAGULATOR MODEL 20 LASER & ACCESSORIESHgm Medical Laser Systems, Inc.K871875MODEL 5050 SURGILASER FOR OB-GYN USELasermatic, Inc.K875314GL-35 COLPOSCOPIC LASER SYSTEMLaser Engineering, Inc.K874615LASER CANNISTER FILTERMedical Marketing, Inc.K880591LASEGUIDE 600A, 600B, 400A, 400B FOR OB-GYN USELaser Peripherals, LLCK880930MDLS 4000,4900,6000,8000,8900 ND:YAG/1700 C02 LASECopper Lasersonics, Inc.

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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