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FDA 510(k)

INDIGO MEDICAL MODEL IDL 830 & MODEL IDL 830E LASER SYSTEMS FOR GENERAL GYNECOLOGICAL APPLICATIONS

K-Number: K963081 · 1997-02-21

ApplicantIndigo Medical, Inc.
Decision Date1997-02-21
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

INDIGO MEDICAL MODEL IDL 830 & MODEL IDL 830E LASER SYSTEMS FOR GENERAL GYNECOLOGICAL APPLICATIONS is the device name listed in this FDA 510(k) record. The listed applicant is Indigo Medical, Inc.. It received FDA 510(k) clearance on 1997-02-21 under 510(k) number K963081. 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 INDIGO MEDICAL MODEL IDL 830 & MODEL IDL 830E LASER SYSTEMS FOR GENERAL GYNECOLOGICAL APPLICATIONS?

INDIGO MEDICAL MODEL IDL 830 & MODEL IDL 830E LASER SYSTEMS FOR GENERAL GYNECOLOGICAL APPLICATIONS is a medical device that received FDA 510(k) clearance on 1997-02-21. The listed applicant is Indigo Medical, Inc.. The 510(k) number is K963081.

When did INDIGO MEDICAL MODEL IDL 830 & MODEL IDL 830E LASER SYSTEMS FOR GENERAL GYNECOLOGICAL APPLICATIONS receive FDA 510(k) clearance?

INDIGO MEDICAL MODEL IDL 830 & MODEL IDL 830E LASER SYSTEMS FOR GENERAL GYNECOLOGICAL APPLICATIONS received FDA 510(k) clearance on 1997-02-21, under 510(k) number K963081.

Who is the listed applicant for INDIGO MEDICAL MODEL IDL 830 & MODEL IDL 830E LASER SYSTEMS FOR GENERAL GYNECOLOGICAL APPLICATIONS?

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

What is the FDA product code for INDIGO MEDICAL MODEL IDL 830 & MODEL IDL 830E LASER SYSTEMS FOR GENERAL GYNECOLOGICAL APPLICATIONS?

The FDA product code for INDIGO MEDICAL MODEL IDL 830 & MODEL IDL 830E LASER SYSTEMS FOR GENERAL GYNECOLOGICAL APPLICATIONS is GEX. This falls under the Gastroenterology category.

Related Clinical Trials

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Other records listing Indigo Medical, 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.

K992262INDIGO PROSTATE SEEDING NEEDLE CARTRIDGE SYSTEMK990851INDIGO LASEROPTIC TREATMENT SYSTEMK963969INDIGO PORTABLE LASER SYSTEM WITH TEMPERATURE FEEDBACK -MODEL IDL 830 (POWER OPTIONS : 25, 20, 15 & 10 WATTS) INDIGO FIBK955758INDIGO MEDICAL MODEL IDL 830EK954195INDIGO PORTABLE LASER SYSTEM, INDDIGO FIBEROPTICS

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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