Edoscopic Dissection Probe 3701-001
Edoscopic Dissection Probe 3701-001 is a Class II device made by Medtronic PS Medical, cleared under FDA 510(k) K945633 on 19 Sep 1995 and listed in FDA GUDID since 13 Jun 2016 (UDI-DI 00643169497689), active as of 22 Oct 2026. One FDA recall is linked to it.
Active
510(k)
Valid until
No expiry
FDA recalls
None ongoingDocuments
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number00643169497689 | Date13 Jun 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK945633 | Date19 Sep 1995 | StatusActive |
Official records
- AccessGUDID record 00643169497689
- FDA 510(k) database K945633
Across registries
- FDA 510(k) K945633 decided 19 Sep 1995 Active
- FDA GUDID UDI-DI 00643169497689 listed 13 Jun 2016 Listed
Recalls
-
- Terminated Z-0049-04
Size mix-up. 13 cm product may be labeled as 21.6 mm and visaversa.
Timeline
- Cleared FDA 510(k) K945633
- Recall initiated FDA recalls Z-0049-04
- Listed FDA GUDID 00643169497689
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Edoscopic Dissection Probe
- Generic name
- Flexible endoscopic scissors, reusable
- Model / reference
- 3701-001
- Primary DI / UDI-DI
- 00643169497689
- 510(k) Number
- FDA product code
- GWG
- GMDN term
- Flexible endoscopic scissors, reusable
- Device class
- Class II
- Regulation number
- 882.1480
- GUDID distribution status
- In Commercial Distribution
- Sterilisation method
- Moist Heat or Steam Sterilization
Similar devices in this category
Other devices filed under Flexible endoscopic scissors, reusable.