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FDA 510(k)

SURGILASE 40S

K-Number: K852470 · 1985-11-13

ApplicantSurgilase, Inc.
Decision Date1985-11-13
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

SURGILASE 40S is the device name listed in this FDA 510(k) record. The listed applicant is Surgilase, Inc.. It received FDA 510(k) clearance on 1985-11-13 under 510(k) number K852470. 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 40S?

SURGILASE 40S is a medical device that received FDA 510(k) clearance on 1985-11-13. The listed applicant is Surgilase, Inc.. The 510(k) number is K852470.

When did SURGILASE 40S receive FDA 510(k) clearance?

SURGILASE 40S received FDA 510(k) clearance on 1985-11-13, under 510(k) number K852470.

Who is the listed applicant for SURGILASE 40S?

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 40S?

The FDA product code for SURGILASE 40S 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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