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FDA 510(k)

PREVENA INCISION MANAGEMENT SYSTEM

K-Number: K100821 · 2010-06-11

ApplicantKci USA, Inc.
Decision Date2010-06-11
Product CodeOMP
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

PREVENA INCISION MANAGEMENT SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Kci USA, Inc.. It received FDA 510(k) clearance on 2010-06-11 under 510(k) number K100821. The device is classified under product code OMP. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PREVENA INCISION MANAGEMENT SYSTEM?

PREVENA INCISION MANAGEMENT SYSTEM is a medical device that received FDA 510(k) clearance on 2010-06-11. The listed applicant is Kci USA, Inc.. The 510(k) number is K100821.

When did PREVENA INCISION MANAGEMENT SYSTEM receive FDA 510(k) clearance?

PREVENA INCISION MANAGEMENT SYSTEM received FDA 510(k) clearance on 2010-06-11, under 510(k) number K100821.

Who is the listed applicant for PREVENA INCISION MANAGEMENT SYSTEM?

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

What is the FDA product code for PREVENA INCISION MANAGEMENT SYSTEM?

The FDA product code for PREVENA INCISION MANAGEMENT SYSTEM is OMP.

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Other records listing Kci USA, Inc. as applicant

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Related Devices (Code: OMP)

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.

K261338RENASYS DYNAFLOW Kit (66807741)Smith & Nephew Medical, Ltd.K253263ConvaVAC™ Negative Pressure Wound Therapy SystemConvatec Limited, Gdc BuildingK253199CURASYS 2 (EMDN0003)CG Bio Co., Ltd.K260646RENASYS EDGE (66803126)Smith & Nephew Medical, Ltd.K261291Nisus NPWT Canister 500-mL (CPC-500)Cork MedicalK254019Wound Geni NPWT SystemBechtel Medical, Inc.

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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