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FDA 510(k)

ACCU-BEAM LAPAROSCOPIC SYSTEM

K-Number: K910978 · 1991-11-07

ApplicantTti Medical
Decision Date1991-11-07
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

ACCU-BEAM LAPAROSCOPIC SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Tti Medical. It received FDA 510(k) clearance on 1991-11-07 under 510(k) number K910978. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ACCU-BEAM LAPAROSCOPIC SYSTEM?

ACCU-BEAM LAPAROSCOPIC SYSTEM is a medical device that received FDA 510(k) clearance on 1991-11-07. The listed applicant is Tti Medical. The 510(k) number is K910978.

When did ACCU-BEAM LAPAROSCOPIC SYSTEM receive FDA 510(k) clearance?

ACCU-BEAM LAPAROSCOPIC SYSTEM received FDA 510(k) clearance on 1991-11-07, under 510(k) number K910978.

Who is the listed applicant for ACCU-BEAM LAPAROSCOPIC SYSTEM?

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

What is the FDA product code for ACCU-BEAM LAPAROSCOPIC SYSTEM?

The FDA product code for ACCU-BEAM LAPAROSCOPIC SYSTEM is GEI.

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Other records listing Tti Medical 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.

K952006ACCU-BEAM FIBER OPTIC HANDPIECEK951895ACCU-BEAM 300W XENON LIGHT SOURCEK945648ACCU-BEAM C02 LASER HANDPIECEK921208ACCU-BEAM TUBE SETK895656ACCU-BEAM WAVEGUIDEK890922ACCU-BEAM YAG FIBER

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Related Devices (Code: GEI)

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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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