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FDA 510(k)

AART GLUTEAL IMPLANT

K-Number: K021839 · 2002-07-16

ApplicantAesthetic and Reconstructive Technologies, Inc.
Decision Date2002-07-16
Product CodeMIB
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

AART GLUTEAL IMPLANT is the device name listed in this FDA 510(k) record. The listed applicant is Aesthetic and Reconstructive Technologies, Inc.. It received FDA 510(k) clearance on 2002-07-16 under 510(k) number K021839. The device is classified under product code MIB. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AART GLUTEAL IMPLANT?

AART GLUTEAL IMPLANT is a medical device that received FDA 510(k) clearance on 2002-07-16. The listed applicant is Aesthetic and Reconstructive Technologies, Inc.. The 510(k) number is K021839.

When did AART GLUTEAL IMPLANT receive FDA 510(k) clearance?

AART GLUTEAL IMPLANT received FDA 510(k) clearance on 2002-07-16, under 510(k) number K021839.

Who is the listed applicant for AART GLUTEAL IMPLANT?

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

What is the FDA product code for AART GLUTEAL IMPLANT?

The FDA product code for AART GLUTEAL IMPLANT is MIB.

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Other records listing Aesthetic and Reconstructive Technologies, 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.

K023678DIMISIL SCAR GELK022306AART SILICONE TUBINGK022511AART CALF IMPLANTK022223AART SILICONE SHEETINGK021820AART SILICONE CARVING BLOCKK021337AART PECTORALIS IMPLANT

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Related Devices (Code: MIB)

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.

K241150MISTI Silicone ImplantKeosan Trading Co.K223051Pre-Formed Silicone BlockInternational Medical Devices, Inc.K222748ShiNeo Silicone ImplantShineo Technology Co., Ltd.K200073AugMENTA Penile ImplantAugmenta, LLCK220760Pre-Formed Penile Silicone BlockInternational Medical Devices, Inc.K193392BioSiCar Silicone ImplantMetalware Technology Corp.

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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