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FDA 510(k)

LASER FORCEPS HANDPIECE

K-Number: K901365 · 1990-08-21

ApplicantLca, Inc.
Decision Date1990-08-21
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

LASER FORCEPS HANDPIECE is the device name listed in this FDA 510(k) record. The listed applicant is Lca, Inc.. It received FDA 510(k) clearance on 1990-08-21 under 510(k) number K901365. 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 LASER FORCEPS HANDPIECE?

LASER FORCEPS HANDPIECE is a medical device that received FDA 510(k) clearance on 1990-08-21. The listed applicant is Lca, Inc.. The 510(k) number is K901365.

When did LASER FORCEPS HANDPIECE receive FDA 510(k) clearance?

LASER FORCEPS HANDPIECE received FDA 510(k) clearance on 1990-08-21, under 510(k) number K901365.

Who is the listed applicant for LASER FORCEPS HANDPIECE?

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

What is the FDA product code for LASER FORCEPS HANDPIECE?

The FDA product code for LASER FORCEPS HANDPIECE is GEX. This falls under the Gastroenterology category.

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Other records listing Lca, 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.

K952792PADLESS ELECTROSURGICAL PENCILK944091THE HOOK-CURVED CLOSED END/ELECT FIBER LASER DELIV SYSK935439SNJ SMOKE EVACUATION SUCTION WANDK935258HYBRID SURGICAL DEVICE MODIFICATIONK925726ALLOY SCALPEL HANDPIECES, MODIFICATIONK931070CLOSED END FIBEROPTIC LASER DELIVERY SYSTEM

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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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