FDA.reportPublic FDA data

Apollo 2-0 Polypropylene Endobariatric Suture

Primary DI
10811955020824
Brand
Apollo 2-0 Polypropylene Endobariatric Suture
Company
Apollo Endosurgery, Inc.
Model
PLY-G02-020-BAR
Device description
Apollo 2-0 Polypropylene Suture to be utilized with the Apollo ESG Dual and Single Channel Endobariatric suture system and the Apollo Revise Dual and Single Channel Endobariatric suture system
Published
2023-01-10
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
QTDEndoscopic Suturing Device For Altering Gastric Anatomy For Weight Loss

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QTDEndoscopic Suturing Device For Altering Gastric Anatomy For Weight LossGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10811955020824PackageGS1235In Commercial Distribution
00811955020827PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081195502082410811955020824
00811955020827008119550208278119550208270811955020827

GMDN Terms#

Term, Definition table
TermDefinition
Suturing unit, single-useA non-powered, hand-held device intended to pass sutures or a needle/suture assembly through tissues/prosthetic materials to facilitate suturing during an endoscopic and/or open surgical procedure; it may also knot, cut and/or tighten the sutures/ligature loop during or after placement. It typically consists of a shaft with hooks, catches, clasps, or forceps-like jaws at the distal end, and a proximal handle with controls. It typically has a pointed/cutting component to create a suture tunnel, and is loaded with the sutures or the suture is inserted through the shaft. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
855-551-3123productcomplaints.us@apolloendo.com

Regulatory Flags#

DUNS number
625064352
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00811955020834OverStitch NXT Endoscopic Suturing SystemESS-ESG-NXTESS-ESG-NXT2024-10-01
10811955020619ORBERA Intragastric Balloon SystemB-4800B-48002015-08-24
00811955020919NXT Tissue Helix ProNXT-THXP-130 NXT-THXP-1302023-11-16
00811955020896OverStitch NXT Endoscopic Suturing SystemESS-G02-NXTESS-G02-NXT2023-11-16
10811955020916NXT Tissue Helix ProNXT-THXP-130 NXT-THXP-1302023-11-16
00811955020933Apollo ESG NXT SystemAPL-ESG-NXTAPL-ESG-NXT2023-11-16
00811955020940Apollo Revise NXT SystemAPL-REV-NXTAPL-REV-NXT2023-11-16
10811955020763X-Tack Endoscopic HeliX Tacking SystemXTACK-160-HXTACK-160-H2021-07-12
10811955020770X-Tack Endoscopic HeliX Tacking SystemXTACK-235-HXTACK-235-H2021-07-12
00811955020735OverStitch Endoscopic Suturing SystemPLY-G02-020-APLPLY-G02-020-APL2019-10-31
10811955020718OverStitch Endoscopic Suturing System SxESS-G02-Sx1ESS-G02-Sx12021-05-26
10811955020664OverStitch Endoscopic Suturing SystemESS-G02-160ESS-G02-1602016-08-19
10811955020671OverStitch Endoscopic Suturing SystemCNH-G01-000CNH-G01-0002016-08-19
10811955020688OverStitch Endoscopic Suturing SystemTHX-165-028THX-165-0282016-10-07
10811955020756X-Tack Endoscopic HeliX Tacking SystemCNH-C01-213-LCNH-C01-213-L2021-07-12
00811955020827Apollo 2-0 Polypropylene Endobariatric SuturePLY-G02-020-BAR2023-01-10
00811955020780APOLLO ESG™ SystemAPL-ESG-1602023-01-10
00811955020797APOLLO ESG Sx™ SystemAPL-ESG-SX12023-01-10
00811955020803APOLLO Revise™ SystemAPL-REV-1602023-01-10
00811955020810APOLLO REVISE™ Sx SystemAPL-REV-Sx12023-01-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00191506060091OverStitch™BOSTON SCIENTIFIC CORPORATIONQTD2025-09-19
00191506060053Tissue HelixBOSTON SCIENTIFIC CORPORATIONQTD2025-07-28
00191506060060NXT Tissue HeliX ProBOSTON SCIENTIFIC CORPORATIONQTD2025-07-28
00191506060107OverStitch NXT ™BOSTON SCIENTIFIC CORPORATIONQTD2025-07-28
00811955020834OverStitch NXT Endoscopic Suturing SystemApollo Endosurgery, Inc.QTD2024-10-01
00811955020933Apollo ESG NXT SystemApollo Endosurgery, Inc.QTD2023-11-16
00811955020940Apollo Revise NXT SystemApollo Endosurgery, Inc.QTD2023-11-16
00811955020827Apollo 2-0 Polypropylene Endobariatric SutureApollo Endosurgery, Inc.QTD2023-01-10
00811955020780APOLLO ESG™ SystemApollo Endosurgery, Inc.QTD2023-01-10
00811955020797APOLLO ESG Sx™ SystemApollo Endosurgery, Inc.QTD2023-01-10
00811955020803APOLLO Revise™ SystemApollo Endosurgery, Inc.QTD2023-01-10
00811955020810APOLLO REVISE™ Sx SystemApollo Endosurgery, Inc.QTD2023-01-10