SureTrac(TM) Elastic Traction System
ETD-F-26-165-C-N,LOCK-00005
1manufacturer
14catalogue numbers in this listing
1510(k) clearance
Who Else Makes It
Registered in Jiangsu.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Micro-Tech (Nanjing) Co., Ltd. | Nan Jing | Jiangsu | Contract manufacturer | 49 |
Record
| Listed by | Micro-Tech (Nanjing) Co., Ltd., China |
|---|---|
| FDA product code | QSW |
| Device type | Endoscopic Traction Device |
| Device class | Class 2 |
| Regulation | 21 CFR 876.4410 |
| Establishment | Contract manufacturer, Contract steriliser, Manufacturer |
| 510(k) | K222354 |
| Record published | 2023-06-28 |
| Record revised | 2025-12-08 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Packaging | Box, case of 25 |
| Sizes | Length 1650 to 2350 mm; outer diameter 2.6 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| ETS10005 | Length 1650 mm | In distribution |
| ETS10008 | Length 2350 mm | In distribution |
| ETS10006 | Length 2350 mm | In distribution |
| ETS00004 | Length 2350 mm | In distribution |
| ETS00006 | Length 2350 mm | In distribution |
| ETS00003 | Length 1650 mm | In distribution |
| ETS10001 | Length 1650 mm | In distribution |
| ETS10004 | Length 2350 mm | In distribution |
| ETS10002 | Length 2350 mm | In distribution |
| ETS00001 | Length 1650 mm | In distribution |
| ETS10003 | Length 1650 mm | In distribution |
| ETS10007 | Length 1650 mm | In distribution |
| ETS00005 | Length 1650 mm | In distribution |
| ETS00002 | Length 2350 mm | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| ProdiGI | Covidien LP | 5 |
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K222354 | 2022-10-03 |
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.