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FDA 510(k)

AMBULASE

K-Number: K852436 · 1986-04-18

ApplicantXanar, Inc.
Decision Date1986-04-18
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

AMBULASE is the device name listed in this FDA 510(k) record. The listed applicant is Xanar, Inc.. It received FDA 510(k) clearance on 1986-04-18 under 510(k) number K852436. 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 AMBULASE?

AMBULASE is a medical device that received FDA 510(k) clearance on 1986-04-18. The listed applicant is Xanar, Inc.. The 510(k) number is K852436.

When did AMBULASE receive FDA 510(k) clearance?

AMBULASE received FDA 510(k) clearance on 1986-04-18, under 510(k) number K852436.

Who is the listed applicant for AMBULASE?

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

What is the FDA product code for AMBULASE?

The FDA product code for AMBULASE is GEX. This falls under the Gastroenterology category.

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Other records listing Xanar, 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.

K861688XANAR CO2 SURGICAL LASER SYSTEM MODEL XAP-15K860496MODEL NY-110 FOR UPPER & LOWER (GU) & PULMONARYK853620MODEL XA-50 - CO2 SURGICAL LASERK850818CO 2 SURGICAL LASER SYSTEM NA-120K850805CO 2 SURGICAL LASER SYSTEM MODEL NA-40K850804CO 2 SURGICAL LASER SYSTEM NA-30

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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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