X-Tack Endoscopic HeliX Tacking System
- Primary DI
- 20811955020753
- Brand
- X-Tack Endoscopic HeliX Tacking System
- Company
- Apollo Endosurgery, Inc.
- Model
- CNH-C01-213-L
- Catalog number
- CNH-C01-213-L
- Device description
- Suture Cinch - Long
- Published
- 2021-07-12
- Public version status
- New
- Distribution status
- In Commercial Distribution
- MRI safety
- MR Safe
- Rx
- true
- OTC
- false
- Sterile
- true
- Single use
- true
Contact Domains#
apolloendo.comProduct Codes#
| Code | Name |
|---|---|
| PKL | Hemostatic Metal Clip For The Gi Tract |
Product Code Classifications#
| Code | Device | Specialty | Class |
|---|---|---|---|
| PKL | Hemostatic Metal Clip For The Gi Tract | Gastroenterology, Urology | 2 |
Premarket Submissions#
| Submission | Supplement |
|---|---|
| K201808 | 000 |
Premarket Details#
Identifiers And Packaging#
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| 20811955020753 | Package | GS1 | 6 | In Commercial Distribution |
| 10811955020756 | Primary | GS1 | 0 | |
| 00811955020759 | Unit of Use | GS1 | 0 |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | UPC-A | EAN-13 |
|---|---|---|---|
| 20811955020753 | 20811955020753 | ||
| 10811955020756 | 10811955020756 | ||
| 00811955020759 | 00811955020759 | 811955020759 | 0811955020759 |
GMDN Terms#
| Term | Definition |
|---|---|
| Gastrointestinal endoscopic clip, short-term | A sterile clip intended to be placed short-term (<=30 days) within the gastrointestinal (GI) tract during an endoscopic procedure for endoscopic marking, haemostasis, tissue approximation, closure of luminal perforations, and/or for treating mucosal/submucosal defects. It is a metallic device with a clasping mechanism; a disposable applicator may be included. This is a single-use device. |
Sterilization Methods#
| Method |
|---|
Contacts#
| Phone | |
|---|---|
| 855-551-3123 | productcomplaints.us@apolloendo.com |
Regulatory Flags#
- DUNS number
- 625064352
- Device count
- 6
- DM exempt
- false
- Premarket exempt
- false
- HCT/P
- false
- Kit
- true
- Combination product
- false
- Lot or batch
- true
- Serial number
- true
- 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 | Catalog | Published |
|---|---|---|---|---|
| 00811955020834 | OverStitch NXT Endoscopic Suturing System | ESS-ESG-NXT | ESS-ESG-NXT | 2024-10-01 |
| 10811955020619 | ORBERA Intragastric Balloon System | B-4800 | B-4800 | 2015-08-24 |
| 00811955020919 | NXT Tissue Helix Pro | NXT-THXP-130 | NXT-THXP-130 | 2023-11-16 |
| 00811955020896 | OverStitch NXT Endoscopic Suturing System | ESS-G02-NXT | ESS-G02-NXT | 2023-11-16 |
| 10811955020916 | NXT Tissue Helix Pro | NXT-THXP-130 | NXT-THXP-130 | 2023-11-16 |
| 00811955020933 | Apollo ESG NXT System | APL-ESG-NXT | APL-ESG-NXT | 2023-11-16 |
| 00811955020940 | Apollo Revise NXT System | APL-REV-NXT | APL-REV-NXT | 2023-11-16 |
| 10811955020763 | X-Tack Endoscopic HeliX Tacking System | XTACK-160-H | XTACK-160-H | 2021-07-12 |
| 10811955020770 | X-Tack Endoscopic HeliX Tacking System | XTACK-235-H | XTACK-235-H | 2021-07-12 |
| 00811955020735 | OverStitch Endoscopic Suturing System | PLY-G02-020-APL | PLY-G02-020-APL | 2019-10-31 |
| 10811955020718 | OverStitch Endoscopic Suturing System Sx | ESS-G02-Sx1 | ESS-G02-Sx1 | 2021-05-26 |
| 10811955020664 | OverStitch Endoscopic Suturing System | ESS-G02-160 | ESS-G02-160 | 2016-08-19 |
| 10811955020671 | OverStitch Endoscopic Suturing System | CNH-G01-000 | CNH-G01-000 | 2016-08-19 |
| 10811955020688 | OverStitch Endoscopic Suturing System | THX-165-028 | THX-165-028 | 2016-10-07 |
| 10811955020756 | X-Tack Endoscopic HeliX Tacking System | CNH-C01-213-L | CNH-C01-213-L | 2021-07-12 |
| 00811955020827 | Apollo 2-0 Polypropylene Endobariatric Suture | PLY-G02-020-BAR | 2023-01-10 | |
| 00811955020780 | APOLLO ESG™ System | APL-ESG-160 | 2023-01-10 | |
| 00811955020797 | APOLLO ESG Sx™ System | APL-ESG-SX1 | 2023-01-10 | |
| 00811955020803 | APOLLO Revise™ System | APL-REV-160 | 2023-01-10 | |
| 00811955020810 | APOLLO REVISE™ Sx System | APL-REV-Sx1 | 2023-01-10 |
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| Primary DI | Brand | Company | Product code | Published |
|---|---|---|---|---|
| 10197344203437 | MEDLINE | MEDLINE INDUSTRIES, INC. | PKL | 2026-04-23 |
| 10197344203444 | MEDLINE | MEDLINE INDUSTRIES, INC. | PKL | 2026-04-23 |
| 00860014822704 | EndoFix Tissue Fixation Device | Endofix Medical Technologies, Inc. | PKL | 2026-02-02 |
| 00860014822711 | Secure Suture Locking Device | Endofix Medical Technologies, Inc. | PKL | 2026-02-02 |
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