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FDA 510(k)

SURGILASE 25, 40, 45, 55, 60, 80, 100 LASER

K-Number: K894396 · 1989-08-07

ApplicantSurgilase, Inc.
Decision Date1989-08-07
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

SURGILASE 25, 40, 45, 55, 60, 80, 100 LASER is the device name listed in this FDA 510(k) record. The listed applicant is Surgilase, Inc.. It received FDA 510(k) clearance on 1989-08-07 under 510(k) number K894396. 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 SURGILASE 25, 40, 45, 55, 60, 80, 100 LASER?

SURGILASE 25, 40, 45, 55, 60, 80, 100 LASER is a medical device that received FDA 510(k) clearance on 1989-08-07. The listed applicant is Surgilase, Inc.. The 510(k) number is K894396.

When did SURGILASE 25, 40, 45, 55, 60, 80, 100 LASER receive FDA 510(k) clearance?

SURGILASE 25, 40, 45, 55, 60, 80, 100 LASER received FDA 510(k) clearance on 1989-08-07, under 510(k) number K894396.

Who is the listed applicant for SURGILASE 25, 40, 45, 55, 60, 80, 100 LASER?

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

What is the FDA product code for SURGILASE 25, 40, 45, 55, 60, 80, 100 LASER?

The FDA product code for SURGILASE 25, 40, 45, 55, 60, 80, 100 LASER is GEX. This falls under the Gastroenterology category.

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Other records listing Surgilase, 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.

K932421SURGILASE/OP 15, 20, 25, 30, 40, 50 CO2 SURG. LASEK924664SURGILASE FIBERLASE CO2 LASER WAVEGUIDEK905006SURGILASE SL 150 SURGICAL LASER SYSTEMK904203SURGILASE SL 50/60 GOLD SURGICAL LASER SYSTEMK902211SURGILASE YAG 100 SURGICAL LASER SYSTEMK900570SURGILASE YAG 100 IN ORTHOPEDIC SURGERY

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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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