SUTURTEK SURGICAL STEEL SUTURE, MODELS SC-S13, SC-S14, SC-S15, SC-S16, SC-S17
FDA 510(k) clearance K063603 · decided 2007-02-07
Clearance details
- K-number
- K063603
- Device name
- SUTURTEK SURGICAL STEEL SUTURE, MODELS SC-S13, SC-S14, SC-S15, SC-S16, SC-S17
- Applicant
- Suturtek Incorporated
- Decision
- Substantially Equivalent
- Date received
- 2006-12-03
- Decision date
- 2007-02-07
- Days to decision
- 66 days
- Clearance type
- Abbreviated
- Product code
- GAQ
- Device class
- 2
- Regulation number
- 878.4495
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Acton, MA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| CoNextions TR Tendon Repair System (K203855) | Conextions Medical | 2022-04-22 |
| Wego-Stainless Steel (K193209) | Foosin Medical Supplies Inc., Ltd. | 2020-02-19 |
| MERISTEEL (K172146) | M/s. Meril Endo Surgery Private Limited. | 2018-02-01 |
| Surgical Stainless Steel Suture, Stainless Steel Suture (K170767) | ETHICON, Inc. | 2017-11-01 |
| DEMESTEEL (STAINLESS STEEL) NON-ABSORBABLE SUTURE (K141007) | Demetech Corp. | 2014-09-25 |
| FERROFIBRE STAINLESS STEEL SUTURE WITH CRIMP (K140127) | Pontis Orthopaedics, LLC | 2014-05-28 |
| FERROFIBRE STAINLESS STEEL SUTURES, MODEL 610 SERIES SIZES (USP) 5-0 TO #5 (K081060) | Core Essence Orthopaedics, LLC | 2008-12-24 |
| SUTURTEK 360 DEGREE STERNAL CLOSURE DEVICE (K082828) | Suturtek Incorporated | 2008-10-14 |
| MODIFICATION TO:SYNTHES (USA) TITANIUM WIRE (K042606) | Synthes (Usa) | 2005-05-27 |
| SYNTHES (USA) TITANIUM WIRE (K041333) | Synthes (Usa) | 2004-08-27 |
| SUTURTEK FASTCLOSE STERNUM CLOSURE DEVICE (K032468) | Suturtek Incorporated | 2003-09-23 |
| TENO FIX (K023594) | Ortheon Medical, LLC | 2003-05-15 |
Recalls involving this device
No recalls on record reference this clearance.