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TriPort15

FDA UDI

Class II (US FDA UDI)

by Advanced Surgical Concepts, Ltd.

Identity

Trade Name
TriPort15 FDA UDI
Generic Name
Laparoscopic multi-instrument access port, single-use FDA UDI
Device Name
This device is intended for use as an endoscopic instrument(s) and/or camera port during minimally invasive abdominal surgery. The ASC TriPort15 is a sterile, disposable endoscopic multi-instrument port. The device consists of the following: • An Introducer that allows the insertion of the Base Retractor into the abdomen through an incision. • A Base Retractor that retracts in an abdominal incision to allow laparoscopic instruments pass through to the abdomen. • A Boot contains three instrument valves and two ports that allow insufflation of the abdomen or venting of electrocautery gases. The Boot maintains pneumoperitoneum when attached and allows specimen removal when detached. FDA UDI
Model / Reference
WA58015T FDA UDI
Description
This device is intended for use as an endoscopic instrument(s) and/or camera port during minimally invasive abdominal surgery. The ASC TriPort15 is a sterile, disposable endoscopic multi-instrument port. The device consists of the following: • An Introducer that allows the insertion of the Base Retractor into the abdomen through an incision. • A Base Retractor that retracts in an abdominal incision to allow laparoscopic instruments pass through to the abdomen. • A Boot contains three instrument valves and two ports that allow insufflation of the abdomen or venting of electrocautery gases. The Boot maintains pneumoperitoneum when attached and allows specimen removal when detached. FDA UDI

Identifiers

Primary DI / UDI-DI
05391530440097 FDA UDI
510(k) Number
K111407 FDA UDI
FDA Product Code
OTJ FDA UDI
GMDN Term
Laparoscopic multi-instrument access port, single-use FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
876.1500 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Laparoscopic multi-instrument access port, single-use

TriPort15 by Advanced Surgical Concepts, Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Laparoscopic multi-instrument access port, single-use.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Advanced Surgical Concepts, Ltd.

Sources (1)

  • FDA UDI ac84f936-fdff-49e8-851d-dbb507be6148 35 fields · synced Jun 8, 2026