ADIPREP ADIPOSE TRANSFER SYSTEM— 510(k) K121005

Name: FDA 510(k) clearance K121005
Creator: U.S. Food and Drug Administration
Published: 2012-09-21

Substantially Equivalent

Harvest Technologies, Corp.

FDA 510(k) clearance K121005 for ADIPREP ADIPOSE TRANSFER SYSTEM, Substantially Equivalent on 2012-09-21. Applicant: Harvest Technologies, Corp.. Device class: 2.

Clearance details

Applicant: Harvest Technologies, Corp.
Product code: Code MUU
Device class: Class 2
Regulation: 21 CFR 878.5040
Advisory panel: General, Plastic Surgery
Date received: 2012-04-03
Decision date: 2012-09-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Plymouth, MA, US

Download summary PDF View on FDA.gov ↗

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Recalls naming K121005

K-number listed on FDA's recall record

Z-0674-2017 — Adiprep Adipose Transfer System. Product Codes: 51431; 51432; 51433; 514001-347.Class II·Terminated·Terumo BCT, Inc.·20161103

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K121005.

Data sourced from openFDA. This site is unofficial and independent of the FDA.