Accuspan® 3605-46
by Pmt Corp.
Accuspan® 3605-46 is a device classified as Unclassified made by Pmt Corp., cleared under FDA 510(k) K845036 on 26 Jun 1985 and listed in FDA GUDID since 1 Aug 2016 (UDI-DI 00650551028727), active as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number00650551028727 | Date1 Aug 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK845036 | Date26 Jun 1985 | StatusActive |
Official records
- AccessGUDID record 00650551028727
- FDA 510(k) database K845036
Across registries
- FDA 510(k) K845036 decided 26 Jun 1985 Active
- FDA GUDID UDI-DI 00650551028727 listed 1 Aug 2016 Listed
Timeline
- Cleared FDA 510(k) K845036
- Listed FDA GUDID 00650551028727
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Accuspan®
- Generic name
- Skin-port tissue expander
- Model / Ref / Catalog
- 3605-46
- Primary DI / UDI-DI
- 00650551028727
- 510(k) Number
- FDA product code
- LCJ
- GMDN term
- Skin-port tissue expander
- Device class
- U
- GUDID distribution status
- In Commercial Distribution
- Size
- Width — 6 CentimeterLength — 14 CentimeterTotal Volume — 320 Centiliter
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