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FDA 510(k)

ERBE APC APPLICATORS, MODELS 20132-106, 20132-107, 20132-109, 20132-110, 20132-11, 20132-112,20132-113, 20132-114, 2013-

K-Number: K992769 · 1999-10-14

ApplicantErbe USA, Inc.
Decision Date1999-10-14
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

ERBE APC APPLICATORS, MODELS 20132-106, 20132-107, 20132-109, 20132-110, 20132-11, 20132-112,20132-113, 20132-114, 2013- is the device name listed in this FDA 510(k) record. The listed applicant is Erbe USA, Inc.. It received FDA 510(k) clearance on 1999-10-14 under 510(k) number K992769. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ERBE APC APPLICATORS, MODELS 20132-106, 20132-107, 20132-109, 20132-110, 20132-11, 20132-112,20132-113, 20132-114, 2013-?

ERBE APC APPLICATORS, MODELS 20132-106, 20132-107, 20132-109, 20132-110, 20132-11, 20132-112,20132-113, 20132-114, 2013- is a medical device that received FDA 510(k) clearance on 1999-10-14. The listed applicant is Erbe USA, Inc.. The 510(k) number is K992769.

When did ERBE APC APPLICATORS, MODELS 20132-106, 20132-107, 20132-109, 20132-110, 20132-11, 20132-112,20132-113, 20132-114, 2013- receive FDA 510(k) clearance?

ERBE APC APPLICATORS, MODELS 20132-106, 20132-107, 20132-109, 20132-110, 20132-11, 20132-112,20132-113, 20132-114, 2013- received FDA 510(k) clearance on 1999-10-14, under 510(k) number K992769.

Who is the listed applicant for ERBE APC APPLICATORS, MODELS 20132-106, 20132-107, 20132-109, 20132-110, 20132-11, 20132-112,20132-113, 20132-114, 2013-?

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

What is the FDA product code for ERBE APC APPLICATORS, MODELS 20132-106, 20132-107, 20132-109, 20132-110, 20132-11, 20132-112,20132-113, 20132-114, 2013-?

The FDA product code for ERBE APC APPLICATORS, MODELS 20132-106, 20132-107, 20132-109, 20132-110, 20132-11, 20132-112,20132-113, 20132-114, 2013- is GEI.

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Other records listing Erbe USA, 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.

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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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