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FDA 510(k)

ACCULITE(TM) OTOPROBE

K-Number: K930981 · 1993-07-28

ApplicantCoherent Medical Group
Decision Date1993-07-28
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

ACCULITE(TM) OTOPROBE is the device name listed in this FDA 510(k) record. The listed applicant is Coherent Medical Group. It received FDA 510(k) clearance on 1993-07-28 under 510(k) number K930981. 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 ACCULITE(TM) OTOPROBE?

ACCULITE(TM) OTOPROBE is a medical device that received FDA 510(k) clearance on 1993-07-28. The listed applicant is Coherent Medical Group. The 510(k) number is K930981.

When did ACCULITE(TM) OTOPROBE receive FDA 510(k) clearance?

ACCULITE(TM) OTOPROBE received FDA 510(k) clearance on 1993-07-28, under 510(k) number K930981.

Who is the listed applicant for ACCULITE(TM) OTOPROBE?

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

What is the FDA product code for ACCULITE(TM) OTOPROBE?

The FDA product code for ACCULITE(TM) OTOPROBE is GEX. This falls under the Gastroenterology category.

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Other records listing Coherent Medical Group 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.

K963339COHERENT ULTRAPULSE CO2 SURGICAL LASERSK960032COHERENT VERSAPULSE AESTHETIC SURGICAL LASERSK932981COHERENT VERSAPULSE 2.1 HOLMIUM SURGICAL LASERSK923575COHERENT VERSAPLUSE 2.1 HOLMIUM SURG. LASERSK932468NOVUS MULTIWAVELENGTHK914136COHERENT VERSAPULSE(TM) 2.1XE/2.1L HOLMI SURG LASE

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Related Devices (Code: GEX)

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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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