FDA.reportPublic FDA data

OverStitch Endoscopic Suturing System

Primary DI
10811955020664
Brand
OverStitch Endoscopic Suturing System
Company
Apollo Endosurgery, Inc.
Model
ESS-G02-160
Catalog number
ESS-G02-160
Device description
Needle Driver and Anchor Exchange
Published
2016-08-19
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HCFInstrument, Ligature Passing And Knot Tying
OCWEndoscopic Tissue Approximation Device

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HCFInstrument, Ligature Passing And Knot TyingGeneral, Plastic Surgery1
OCWEndoscopic Tissue Approximation DeviceGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K081853000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K081853000OVERSTITCH ENDOSCOPIC SUTURE SYSTEMApollo Endosurgery, Inc.2008-08-18OCW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20811955020661PackageGS13In Commercial Distribution
10811955020664PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2081195502066120811955020661
1081195502066410811955020664

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
Kit
true
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
00811955020735OverStitch Endoscopic Suturing SystemPLY-G02-020-APLPLY-G02-020-APL2019-10-31
10811955020718OverStitch Endoscopic Suturing System SxESS-G02-Sx1ESS-G02-Sx12021-05-26
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

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14026704937056MINILAPTELEFLEX INCORPORATEDOCW2026-03-31
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00198506082221ELMED INCORPORATEDELMED INCORPORATEDHCF2025-10-02
G453521053112M0PEAK MEDICALPeak Medical Distribution Inc.HCF2025-10-01
00191506060091OverStitch™BOSTON SCIENTIFIC CORPORATIONOCW2025-09-19
08904332600766MediflexENDOSYS HEALTHCARE INDIA PRIVATE LIMITEDHCF2025-05-19
00191506049126OverStitch™BOSTON SCIENTIFIC CORPORATIONOCW2025-02-17
10888277368309MEDLINE RENEWALMEDLINE INDUSTRIES, INC.HCF2025-01-29
14026704737946MINILAPTELEFLEX INCORPORATEDOCW2024-11-05
14026704737953MINILAPTELEFLEX INCORPORATEDOCW2024-11-05
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