histologicswc.comSoft K-Bride - Wound debridement and tissue sampling device, trumpet shaped for body surfaces.
2019-11-10
HISTOLOGICS LLC
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3008004502 | 3008004502 | HISTOLOGICS LLC | 1 | N | 2026-01-01 | 4095 E La Palma Ave Ste N Anaheim CA US 92807 |
GUDID Contact Samples#
| Source GUDID | Product | Phone | |
|---|---|---|---|
| 00860275000316 | SoftBiopsy - Gynecological biopsy device for tissue collection, storage, and transport. | 888-738-9757 | Histologics@gmail.com |
| 00860275000323 | Soft-ECC - Endocervical curette system for tissue collection, storage, and transport. | 888-738-9757 | Histologics@gmail.com |
| 00860275000330 | Soft-ECC-S - Endocervical curette system (small size) for tissue collection, storage, and transport. | 888-738-9757 | Histologics@gmail.com |
| 00860275000347 | Soft K-Bride - Wound debridement and tissue sampling device, trumpet shaped for body surfaces. | 888-235-2275 | Support@histologicswc.com |
| 00860275000347 | Soft K-Bride - Wound debridement and tissue sampling device, trumpet shaped for body surfaces. | 888-738-9757 | Histologics@gmail.com |
| 00860275000354 | Soft K-Rette - Wound debridement and tissue sampling device, tapered brush tip for wound tunnels. | 888-738-9757 | Histologics@gmail.com |
| 00860275000354 | Soft K-Rette - Wound debridement and tissue sampling device, tapered brush tip for wound tunnels. | 888-235-2275 | Support@histologicswc.com |
| 00860275000361 | Soft K-Cot(R) - The Soft K-Cot(R) is a single-use, nitrile, finger cot, brush/curette, which is placed over an already gloved finger. | 888-738-9757 | Histologics@gmail.com |
| 00860275000361 | Soft K-Cot(R) - The Soft K-Cot(R) is a single-use, nitrile, finger cot, brush/curette, which is placed over an already gloved finger. | 888-235-2275 | Support@histologicswc.com |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 109668 | 1507820702 | K011488 | SPIRABRUSH CX BIOPSY INSTRUMENT | HFB | 2002-02-22 |
| 109668 | 1114324096 | ||||
| 109668 | 1924965256 | ||||
| 109668 | 1005070678 | ||||
| 109668 | 1688544876 | ||||
| 109668 | 1773827752 | ||||
| 109668 | 1804211079 | ||||
| 109668 | 1832579202 | ||||
| 109668 | 1920961806 | ||||
| 109668 | 2061693531 |
Product Codes Associated With Registrations#
| Product code | Registration listing records | Latest decision |
|---|---|---|
| HFB | 1 | 2002-02-22 |
GUDID#
Soft K-Rette - Wound debridement and tissue sampling device, tapered brush tip for wound tunnels.
2019-11-10
Soft K-Cot(R) - The Soft K-Cot(R) is a single-use, nitrile, finger cot, brush/curette, which is placed over an already gloved finger.
2021-07-25
SoftBiopsy - Gynecological biopsy device for tissue collection, storage, and transport.
2019-11-10
Soft-ECC - Endocervical curette system for tissue collection, storage, and transport.
2019-11-10
Soft-ECC-S - Endocervical curette system (small size) for tissue collection, storage, and transport.
2019-11-10
SoftBiopsy - Gynecological biopsy device for tissue collection, storage, and transport.
2019-11-10
Soft-ECC - Endocervical curette system for tissue collection, storage, and transport.
2019-11-10
Soft-ECC-S - Endocervical curette system (small size) for tissue collection, storage, and transport.
2019-11-10
Soft K-Bride - Wound debridement and tissue sampling device, trumpet shaped for body surfaces.
2019-11-10
Soft K-Rette - Wound debridement and tissue sampling device, tapered brush tip for wound tunnels.
2019-11-10
SpiraBrush CX - SpiraBrush CX is intended for obtaining a biopsy of visible exocervical lesions for the purpose of obtaining tissue diagnosis in women with intraepithelial disease.
2016-09-28