510(k) K003956
- Device
- BARD ENDOCINCH SUTURING SYSTEM # 000452; 000454; 000595
- Applicant
- C.R. BARD, INC.
- 510(k) number
- K003956
- Product code
- ODE
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2001-01-05
- Date received
- 2000-12-21
- Regulation
- 876.1500
- Classification name
- Endoscopic Suture/plication System, Gastroesophageal Reflux Disease (gerd)
- Medical specialty
- Gastroenterology/Urology
- Review panel
- Gastroenterology/Urology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- Yes
Applicant Contact#
- Contact
- BETH A ZIS
- Address
- 129 Concord Rd. Bldg. #3 Billerica MA US 01821 01821
FDA Registration Numbers#
- 1721676
- 3015225571
- 3032855354
- 3012536737
- 3015309643
- 1721504
- 3033508651
- 1724474
- 3006950086
- 3033589330
- 3009039068
Source Documents#
Other 510(k) Records For Product Code ODE #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K233240 | GERDX-System | G-Surg GmbH | 2024-06-21 |
| K240879 | EsophyX Z+ Device with SerosaFuse Fasteners and Accessories | Endogastric Solutions, Inc. | 2024-04-26 |
| K172811 | EsophyX Z, EsophyX2 HD | Endogastric Solutions, Inc. | 2017-10-19 |
| K171307 | EsophyX2 HD Device with SerosaFuse Fasteners and Accessories, EsophyX Z Device with SerosaFuse Fasteners and Accessories | Endogastric Solutions, Inc. | 2017-06-22 |
| K160960 | EsophyX® Z Device with SerosaFuse Fasteners and Accessories | Endogastric Solutions, Inc. | 2016-05-01 |
| K151001 | MUSE System | Medigus , Ltd. | 2015-06-05 |
| K143645 | EsophyX® Z Fastener Delivery Device | Endogastric Solutions, Inc. | 2015-03-04 |
| K143634 | MUSE System | Medigus , Ltd. | 2015-01-20 |
| K142113 | ESOPHYX2 HD | Endogastric Solutions, Inc. | 2014-09-30 |
| K132151 | SRS ENDOSCOPIC STAPLING SYSTEM | Medigus , Ltd. | 2014-03-19 |
| K120299 | SRS ENDOSCOPIC STAPLING SYSTEM | Medigus , Ltd. | 2012-05-18 |
| K092400 | ENDOGASTRIC SOLUTIONS ESOPHYX2 SYSTEM WITH SEROSAFUSE FASTENER AND ACCESSORIES, MODEL 2.7.5 | Endogastric Solutions, Inc. | 2009-11-06 |
| K072125 | ENDOSCOPIC PLICATION SYSTEM, EPS, EPLICATOR, PLICATOR INSTRUMENT | Ndo Surgical, Inc. | 2007-10-18 |
| K071553 | ENDOSCOPIC PLICATION SYSTEM; EPS; PLICATOR | Ndo Surgical, Inc. | 2007-09-18 |
| K071651 | EGS SEROSAFUSE IMPLANTABLE FASTENERS, ASSOCIATED DELIVERY DEVICES AND ACCESSORIES | Endogastric Solutions, Inc. | 2007-09-14 |
Legacy Summary#
summary
FDA Review#
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