Atlas FDA

MCGHAN MAGNA-SITE(TM) TISSUE EXPANDER

FDA 510(k) clearance K862203 · decided 1986-07-23

Clearance details

K-number
K862203
Device name
MCGHAN MAGNA-SITE(TM) TISSUE EXPANDER
Applicant
Mcghan Medical Corp.
Decision
Substantially Equivalent
Date received
1986-06-10
Decision date
1986-07-23
Days to decision
43 days
Clearance type
Traditional
Product code
LCJ
Device class
U
Medical specialty
Unknown
Advisory committee
Unknown
Location
Santa Barbara, CA, US
Third-party review
No
Expedited review
No

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Devices cleared under the same product code - the starting set for predicate research.

RecordFirmDate
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AlloX2 Pro Tissue Expanders (K214124)Sientra, Inc.2023-06-08
Sientra, inc. Portfinder (K221127)Sientra, Inc.2023-05-10
Natrelle 133 Plus MICROCELL Tissue Expander (K180826)Allergan2018-12-21
CPX 4 Breast Tissue Expander with Smooth Surface (K182335)Mentor Worldwide, LLC2018-09-25
Natrelle 133S Tissue Expander (K182054)Allergan2018-08-29
Unger Quad Injector (K161483)Stradis Healthcare2016-10-31
ARTOURA Breast Tissue Expanders with Smooth Surface (K161176)Mentor Worldwide, LLC2016-05-23

Recalls involving this device

RecordFirmDate
Natrelle 133 Tissue Expanders (also named style 133 BIOSPAN Tissue Expander and Mcghan Mag recall (Z-2455-2019)Allergan PLC2019-09-11
Natrelle 133 Tissue Expanders w/Suture Tabs BIOCELL Full Height Variable Projection with M recall (Z-2457-2019)Allergan PLC2019-09-11
McGhan Croissant-Shaped Tissue Expanders, Style 134 Product Usage: intended for temporary recall (Z-2458-2019)Allergan PLC2019-09-11
Natrelle 133 Series Tissue Expanders Product Usage: Natrelle 133 Series Tissue Expander is recall (Z-2103-2015)Allergan Inc2015-07-18