Mammotome G011F
by Devicor Medical Products, Inc.
Mammotome G011F is a Class II device made by Devicor Medical Products, Inc., cleared under FDA 510(k) K943863 on 29 Dec 1994 and listed in FDA GUDID since 4 Feb 2022 (UDI-DI 00841911101123), 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 | Number00841911101123 | Date4 Feb 2022 | StatusListed |
| United States | FDA 510(k)SESE | NumberK943863 | Date29 Dec 1994 | StatusActive |
Official records
- AccessGUDID record 00841911101123
- FDA 510(k) database K943863
Across registries
- FDA 510(k) K943863 decided 29 Dec 1994 Active
- FDA GUDID UDI-DI 00841911101123 listed 4 Feb 2022 Listed
Timeline
- Cleared FDA 510(k) K943863
- Listed FDA GUDID 00841911101123
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Mammotome
- Generic name
- Needle guide, single-use
- Model / Ref / Catalog
- G011F
- Primary DI / UDI-DI
- 00841911101123
- 510(k) Number
- FDA product code
- IYN
- GMDN term
- Needle guide, single-use
- Device class
- Class II
- Regulation number
- 892.1550
- GUDID distribution status
- In Commercial Distribution
- Size
- Needle Gauge — 11 Gauge
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