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FDA 510(k)

SURGILASE/OP 15, 20, 25, 30, 40, 50 CO2 SURG. LASE

K-Number: K932421 · 1993-10-15

ApplicantSurgilase, Inc.
Decision Date1993-10-15
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

SURGILASE/OP 15, 20, 25, 30, 40, 50 CO2 SURG. LASE is the device name listed in this FDA 510(k) record. The listed applicant is Surgilase, Inc.. It received FDA 510(k) clearance on 1993-10-15 under 510(k) number K932421. 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/OP 15, 20, 25, 30, 40, 50 CO2 SURG. LASE?

SURGILASE/OP 15, 20, 25, 30, 40, 50 CO2 SURG. LASE is a medical device that received FDA 510(k) clearance on 1993-10-15. The listed applicant is Surgilase, Inc.. The 510(k) number is K932421.

When did SURGILASE/OP 15, 20, 25, 30, 40, 50 CO2 SURG. LASE receive FDA 510(k) clearance?

SURGILASE/OP 15, 20, 25, 30, 40, 50 CO2 SURG. LASE received FDA 510(k) clearance on 1993-10-15, under 510(k) number K932421.

Who is the listed applicant for SURGILASE/OP 15, 20, 25, 30, 40, 50 CO2 SURG. LASE?

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/OP 15, 20, 25, 30, 40, 50 CO2 SURG. LASE?

The FDA product code for SURGILASE/OP 15, 20, 25, 30, 40, 50 CO2 SURG. LASE is GEX. This falls under the Gastroenterology category.

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Other records listing Surgilase, Inc. as applicant

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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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