Product Code: OOD FDA class 2 21 CFR 878.3300

Surgical Film

General, Plastic Surgery

The Surgical Film (product code OOD) is a Class 2 implantable surgical device regulated under 21 CFR 878.3300 in the General, Plastic Surgery specialty (SU), cleared via 510(k). It is intended to reinforce soft tissue or bone where weakness exists, support temporary wound healing, and reinforce urological, gynecological, or gastrointestinal soft tissues or hernia and fascial defects; it may also help minimize tissue attachment to the device upon contact with viscera. The device is flagged as both an implant and life-sustaining or life-supporting, indicating its critical reconstructive function.

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510(k)s

FEI Numbers

Registration Numbers

Unique Applicants

Years Active

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Basic Information

Product Code: OOD
Device Class: FDA class 2
Regulation Number: 878.3300
Medical Specialty: General, Plastic Surgery
Review Panel: SU
Submission Type: 1

Device Characteristics

✗

GMP Exempt

✓

Implant

✓

Life Sustain/Support

✗

Third Party

—

Summary Malfunction Reporting

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.

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 13 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K233999	GalaFLEX LITE Scaffold	Apr 09, 2024	Substantially Equivalent	Tepha, Inc.
K202425	SurgiLattice scaffold	Aug 19, 2021	Substantially Equivalent	Tepha, Inc.
K162922	GalaFORM 3D	Feb 23, 2017	Substantially Equivalent	Tepha, Inc.
K161424	Phasix Mesh	Sep 29, 2016	Substantially Equivalent	C.R. Bard, Inc.
K161092	GalaSHAPE 3D	Aug 23, 2016	Substantially Equivalent	Tepha, Inc.
K142818	Phasix Mesh	Mar 31, 2015	Substantially Equivalent	C. R. Bard
K140533	GALAFLEX MESH	May 21, 2014	Substantially Equivalent	Tepha, Inc.
K130326	TEPHAFLEX MELTBLOWN CONSTRUCT	May 07, 2013	Substantially Equivalent	Tepha, Inc.
K113723	TEPHAFLEX MESH	Feb 15, 2012	Substantially Equivalent	Tepha, Inc.
K113721	TEPHAFLEX LIGHT MESH	Feb 15, 2012	Substantially Equivalent	Tepha, Inc.
K111946	TEPHAFLEX MESH	Sep 26, 2011	Substantially Equivalent	Tepha, Inc.
K091633	TEPHAFLEX SURGICAL FILM	Aug 07, 2009	Substantially Equivalent	Tepha, Inc.
K070894	TEPHAFLEX SURGICAL MESH	Apr 13, 2007	Substantially Equivalent	Tepha, Inc.