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FDA 510(k)

ACCU-BEAM FIBER OPTIC HANDPIECE

K-Number: K952006 · 1995-05-31

ApplicantTti Medical
Decision Date1995-05-31
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

ACCU-BEAM FIBER OPTIC HANDPIECE is the device name listed in this FDA 510(k) record. The listed applicant is Tti Medical. It received FDA 510(k) clearance on 1995-05-31 under 510(k) number K952006. The device is classified under product code GEX. It was reviewed by the SU advisory panel. Product code GEX falls under the category of Gastroenterology, which includes gastrointestinal diagnostic and therapeutic devices. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ACCU-BEAM FIBER OPTIC HANDPIECE?

ACCU-BEAM FIBER OPTIC HANDPIECE is a medical device that received FDA 510(k) clearance on 1995-05-31. The listed applicant is Tti Medical. The 510(k) number is K952006.

When did ACCU-BEAM FIBER OPTIC HANDPIECE receive FDA 510(k) clearance?

ACCU-BEAM FIBER OPTIC HANDPIECE received FDA 510(k) clearance on 1995-05-31, under 510(k) number K952006.

Who is the listed applicant for ACCU-BEAM FIBER OPTIC HANDPIECE?

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 FIBER OPTIC HANDPIECE?

The FDA product code for ACCU-BEAM FIBER OPTIC HANDPIECE is GEX. This falls under the Gastroenterology category.

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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.

K951895ACCU-BEAM 300W XENON LIGHT SOURCEK945648ACCU-BEAM C02 LASER HANDPIECEK921208ACCU-BEAM TUBE SETK910978ACCU-BEAM LAPAROSCOPIC SYSTEMK895656ACCU-BEAM WAVEGUIDEK890922ACCU-BEAM YAG FIBER

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Related Devices (Code: GEX)

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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