Ethibond Excel
Green/White/Light Green Braided Polyester, Nonabsorbable Surgical Suture
1manufacturer
175catalogue numbers in this listing
3510(k) clearances naming this product code
2recalls on this code
Who Else Makes It
Registered in Shandong.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Foosin Medical Supplies Inc.ltd | Weihai | Shandong | Manufacturer | 8 |
Record
| Listed by | Ethicon, Inc., United States |
|---|---|
| FDA product code | GAQ |
| Device type | Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile |
| Device class | Class 2 |
| Regulation | 21 CFR 878.4495 |
| Establishment | Contract manufacturer, Specification developer, Manufacturer, Exporter |
| 510(k) | K946173 |
| Record published | 2015-09-01 |
| Record revised | 2026-04-13 (version 9) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Packaging | Box of 12, box of 36, box of 24 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| MX551 | In distribution | |
| D9329 | In distribution | |
| D6034 | In distribution | |
| SXX50 | In distribution | |
| X519H | In distribution | |
| X692G | In distribution | |
| X581H | In distribution | |
| X524H | In distribution | |
| X934H | In distribution | |
| D8478 | In distribution | |
| D9498 | In distribution | |
| X304H | In distribution | |
| X513H | In distribution | |
| X522H | In distribution | |
| D6056 | In distribution | |
| D7372 | In distribution | |
| X114H | In distribution | |
| X518H | In distribution | |
| D5666 | In distribution | |
| SXP86 | In distribution | |
| D6076 | In distribution | |
| D8863 | In distribution | |
| D8741 | In distribution | |
| D9190 | In distribution | |
| D8245 | In distribution | |
| D9885 | In distribution | |
| X681G | In distribution | |
| D7446 | In distribution | |
| D9679 | In distribution | |
| D9690 | In distribution | |
| D7447 | In distribution | |
| D7414 | In distribution | |
| D7129 | In distribution | |
| MX763 | In distribution | |
| PXX72 | In distribution | |
| D9171 | In distribution | |
| MPX27 | In distribution | |
| D9556 | In distribution | |
| D8316 | In distribution | |
| D8528 | In distribution | |
| B409T | In distribution | |
| D9014 | In distribution | |
| D6803 | In distribution | |
| D9830 | In distribution | |
| D6090 | In distribution | |
| D6996 | In distribution | |
| D8172 | In distribution | |
| D6296 | In distribution | |
| X425H | In distribution | |
| D5519 | In distribution | |
| X521H | In distribution | |
| D8274 | In distribution | |
| D8319 | In distribution | |
| MX563 | In distribution | |
| D9432 | In distribution | |
| D9769 | In distribution | |
| D7295 | In distribution | |
| SXP02 | In distribution | |
| X550H | In distribution | |
| D7810 | In distribution | |
| D8515 | In distribution | |
| X727H | In distribution | |
| D8230 | In distribution | |
| D6941 | In distribution | |
| D8705 | In distribution | |
| D7809 | In distribution | |
| D6569 | In distribution | |
| D9254 | In distribution | |
| D9311 | In distribution | |
| D8867 | In distribution | |
| D9070 | In distribution | |
| X664H | In distribution | |
| D8585 | In distribution | |
| D8505 | In distribution | |
| D9646 | In distribution | |
| D8516 | In distribution | |
| D5844 | In distribution | |
| X698G | In distribution | |
| DC494 | In distribution | |
| MB66G | In distribution | |
| SXX54 | In distribution | |
| D7520 | In distribution | |
| D10024 | In distribution | |
| MX833 | In distribution | |
| DC423 | In distribution | |
| D6165 | In distribution | |
| MPX77 | In distribution | |
| D9082 | In distribution | |
| D5862 | In distribution | |
| X905H | In distribution | |
| D5865 | In distribution | |
| X523H | In distribution | |
| 10X42 | In distribution | |
| D8527 | In distribution | |
| D9079 | In distribution | |
| D8169 | In distribution | |
| X728H | In distribution | |
| D8665 | In distribution | |
| D7909 | In distribution | |
| D8890 | In distribution | |
| D10069 | In distribution | |
| D9129 | In distribution | |
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| D9132 | In distribution | |
| X717H | In distribution | |
| D8309 | In distribution | |
| D7652 | In distribution | |
| DC400 | In distribution | |
| D8083 | In distribution | |
| D9974 | In distribution | |
| X548H | In distribution | |
| D5475 | In distribution | |
| D9328 | In distribution | |
| D8674 | In distribution | |
| D8725 | In distribution | |
| D8424 | In distribution | |
| X184H | In distribution | |
| D9940 | In distribution | |
| D7056 | In distribution | |
| D5812 | In distribution | |
| D5757 | In distribution | |
| D8611 | In distribution | |
| D10097 | In distribution | |
| D5286 | In distribution | |
| D9939 | In distribution | |
| D8363 | In distribution | |
| X975H | In distribution | |
| D9379 | In distribution | |
| X935H | In distribution | |
| D9976 | In distribution | |
| D5086 | In distribution | |
| D9985 | In distribution | |
| D8438 | In distribution | |
| D10118 | In distribution | |
| CX42D | In distribution | |
| D9209 | In distribution | |
| D7805 | In distribution | |
| D6959 | In distribution | |
| X423H | In distribution | |
| D9661 | In distribution | |
| D8558 | In distribution | |
| DC406 | In distribution | |
| D9279 | In distribution | |
| D5662 | In distribution | |
| D8987 | In distribution | |
| D9692 | In distribution | |
| D6798 | In distribution | |
| D8194 | In distribution | |
| D9876 | In distribution | |
| D7560 | In distribution | |
| D7924 | In distribution | |
| MX523 | In distribution | |
| D8518 | In distribution | |
| MPX17 | In distribution | |
| D9838 | In distribution | |
| X763H | In distribution | |
| X926H | In distribution | |
| DC650 | In distribution | |
| D7630 | In distribution | |
| D9890 | In distribution | |
| D9966 | In distribution | |
| D8612 | In distribution | |
| DC419 | In distribution | |
| D8940 | In distribution | |
| D9146 | In distribution | |
| DC557 | In distribution | |
| X806H | In distribution | |
| D7214 | In distribution | |
| D7576 | In distribution | |
| D9464 | In distribution | |
| CX26D | In distribution | |
| D9958 | In distribution | |
| D9533 | In distribution | |
| D4997 | In distribution | |
| D8337 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| DemeSTEEL | Demetech Corp. | 150 |
| Deknatel | Teleflex Medical LLC | 94 |
| Ethicon | Ethicon, Inc. | 73 |
| Steel | Covidien LP | 44 |
| Acier | Peters Surgical | 43 |
| E-Pack | Ethicon, Inc. | 17 |
| Ethi-PAK | Ethicon, Inc. | 11 |
| Steel Wire | Resorba Medical GmbH | 10 |
| Steelex | B Braun Surgical SA | 7 |
| Valkyrie | Surgical Specialties México, S. de R.L. de C.V. | 6 |
| Fumedica | Surgical Specialties México, S. de R.L. de C.V. | 6 |
| Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile | Synthes Gmbh | 6 |
Showing 12 of 26. All products under Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K170767 | 2017-11-01 |
| K946173 | 1995-01-09 |
| K931271 | 1994-01-07 |
Recalls Naming This Product
2 recalls name this product by its own identifiers, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Ethicon, Inc. | 510(k) number | 2019-04-19 | Class II | Material/Component Contamination | Possibility that a suture raw material containing high endotoxin levels was used in the manufacturing of this lot | 1296 eaches | 2021-02-05 |
| Ethicon, Inc. | 510(k) number | 2019-04-19 | Class II | Material/Component Contamination | Possibility that a suture raw material containing high endotoxin levels was used in the manufacturing of this lot | 36 eaches | 2021-02-05 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.