FDA.reportPublic FDA data

OverStitch Endoscopic Suturing System

Primary DI
00811955020735
Brand
OverStitch Endoscopic Suturing System
Company
Apollo Endosurgery, Inc.
Model
PLY-G02-020-APL
Catalog number
PLY-G02-020-APL
Device description
Apollo 2-0 Polypropylene Suture to be utilized with the OverStitch Endoscopic Suturing System
Published
2019-10-31
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GAWSuture, Nonabsorbable, Synthetic, Polypropylene

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GAWSuture, Nonabsorbable, Synthetic, PolypropyleneGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K191439000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K191439000OverStitch 2-0 Polypropylene SutureApollo Endosurgery2019-08-29OCW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10811955020732PackageGS112In Commercial Distribution
00811955020735PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081195502073210811955020732
00811955020735008119550207358119550207350811955020735

GMDN Terms#

Term, Definition table
TermDefinition
Polyolefin suture, monofilamentA single-strand (monofilament), synthetic, non-bioabsorbable thread made of a polyolefin (e.g., polypropylene, polyethylene, polytetrafluoroethylene, polyvinylidene fluoride) intended to join (i.e., approximate) the edges of a soft-tissue wound or incision by stitching or to ligate soft tissues; it may include an attached needle intended to be disposed of after single use. The thread provides temporary wound support until the wound sufficiently heals to withstand normal stress. It is not a barbed suture and does not include antimicrobial agents/materials. This is a single-use device intended to be used in a sterile condition.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
625064352
Device count
1
Lot or batch
true
Serial number
true
Expiration date on label
true

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
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
10811955020824Apollo 2-0 Polypropylene Endobariatric SuturePLY-G02-020-BAR2023-01-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08903837037824TruleneHEALTHIUM MEDTECH LIMITEDGAW2024-07-11
07757093024767SUTUMEDUnilene S.A.C.GAW2023-01-09
07757093024828SUTUMEDUnilene S.A.C.GAW2023-01-09
07757093024859SUTUMEDUnilene S.A.C.GAW2023-01-09
07757093024873SUTUMEDUnilene S.A.C.GAW2023-01-09
07757093025092SUTUMEDUnilene S.A.C.GAW2023-01-09
07757093025115SUTUMEDUnilene S.A.C.GAW2023-01-09
07757093025146SUTUMEDUnilene S.A.C.GAW2023-01-09
07757093025184SUTUMEDUnilene S.A.C.GAW2023-01-09
07757093025290SUTUMEDUnilene S.A.C.GAW2023-01-09
07757093025313SUTUMEDUnilene S.A.C.GAW2023-01-09
07757093025467SUTUMEDUnilene S.A.C.GAW2023-01-09
07757093025610SUTUMEDUnilene S.A.C.GAW2023-01-09
07757093025702SUTUMEDUnilene S.A.C.GAW2023-01-09
07757093025726SUTUMEDUnilene S.A.C.GAW2023-01-09
07757093025740SUTUMEDUnilene S.A.C.GAW2023-01-09
07757093025832SUTUMEDUnilene S.A.C.GAW2023-01-09
07757093026044SUTUMEDUnilene S.A.C.GAW2023-01-09
07757093026136SUTUMEDUnilene S.A.C.GAW2023-01-09
07757093026150SUTUMEDUnilene S.A.C.GAW2023-01-09
07757093026280SUTUMEDUnilene S.A.C.GAW2023-01-09
07757093026518SUTUMEDUnilene S.A.C.GAW2023-01-09
07757093680543SUTUMEDUnilene S.A.C.GAW2023-01-09
07757093023760SUTUMEDUnilene S.A.C.GAW2023-01-07
07757093023838SUTUMEDUnilene S.A.C.GAW2023-01-07
07757093023869SUTUMEDUnilene S.A.C.GAW2023-01-07
07757093023890SUTUMEDUnilene S.A.C.GAW2023-01-07
07757093023968SUTUMEDUnilene S.A.C.GAW2023-01-07
07757093024033SUTUMEDUnilene S.A.C.GAW2023-01-07
07757093024101SUTUMEDUnilene S.A.C.GAW2023-01-07