510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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OODClass II

Surgical Film

21 CFR 878.3300 / General, Plastic Surgery
FDA source (opens on fda.gov)

OOD is the FDA product code for Surgical Film, a class II device type, regulated under 21 CFR 878.3300. FDA's definition for this code reads: "To be implanted to reinforce soft tissue or bone where weakness exists. Intended to be used wherever temporary wound support is required, to reinforce soft tissues where weakness exists in the urological, gynecological, or gastrointestinal anatomy, or for the repair of hernia or other fascial defects that require the...". As of , FDA records hold 13 510(k) clearances under this code, the most recent dated , and one recall.

Classification record

Product code
OOD
Device name
Surgical Film
FDA definition
To be implanted to reinforce soft tissue or bone where weakness exists. Intended to be used wherever temporary wound support is required, to reinforce soft tissues where weakness exists in the urological, gynecological, or gastrointestinal anatomy, or for the repair of hernia or other fascial defects that require the addition of a reinforcing or bridging material to obtain the desired surgical result. The absorbable protective film also may help minimize the potential for tissue attachment to the device in case of direct contact with the viscera.
Regulation
21 CFR 878.3300
Device class
Class II
Review panel
General, Plastic Surgery
Submission type
510(k)
Implant
Yes
Life sustaining or supporting
Yes
GMP exempt
No
Third party review eligible
No
Ingested clearances
13
Ingested recalls
1

Clearances, product code OOD

By decision year
13 clearances under product code OOD with a decision year between 2007 and 2024, 2012 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code OOD by decision year
YearClearances
20071
20091
20111
20122
20131
20141
20151
20162
20171
20211
20241

Applicants with the most clearances

Product code OOD
Applicants holding the most 510(k) clearances under product code OOD
ApplicantClearances
Tepha, Inc.10
Bard Access Systems, Inc.1
C.R. Bard Inc1
Tepha, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code