bkmedical.com
bkultrasound.comUltrasound System 1300
Bk Medical Aps
BK MEDICAL APS
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 9680269 | 3003705156 | BK MEDICAL APS | 1 | N | 2026-01-01 | MILEPARKEN 34 HERLEV Hovedstaden DK DK-2730 |
GUDID Contact Samples#
| Source GUDID | Product | Phone | |
|---|---|---|---|
| 05704916000684 | Single-Use Biopsy guide - Sterile packed. Bore diameter 2.1 mm; angle of insertion 17.7° to the long axis of the transducer | +4544528100 | info@bkmedical.com |
| 05704916000707 | Extended, Single-Use Biopsy Guide - Sterile-packed. Extended. Bore diameter 1.6mm; angle of insertion 17.7° to the long axis of the transducer | +4544528100 | info@bkmedical.com |
| 05704916000721 | Single-Use Biplane Biopsy Guide - Sterile packed. Bore diameter 1.6 mm; angle of insertion 19° to the long axis of the transducer | +4544528100 | info@bkmedical.com |
| 05704916000745 | Single-Use Biplane Biopsy Guide - Sterile packed. Bore diameter 2.1 mm; angle of insertion 19° to the long axis of the transducer | +4544528100 | info@bkmedical.com |
| 05704916000769 | Single-Use Endfire Biopsy Guide - Sterile-packed. Bore diameter 1.6 mm; angle of insertion 0° to the long axis of the transducer | +4544528100 | info@bkmedical.com |
| 05704916000783 | Single-Use Dual Biopsy Guide - Sterile packed. Bore diameter 1.6 mm; angle of insertion 0° and 19° to the long axis of the transducer | +4544528100 | info@bkmedical.com |
| 05704916000806 | Single-Use Needle Guide - Sterile packed. Accepts needles 10-20 gauge; angle of insertion 30° to the image axis | +4544528100 | info@bkultrasound.com |
| 05704916000820 | Single-Use Needle Guide - Sterile-packed. Includes: 3-angle insert for 10-20 gauge needles (9 pcs), free-angle insert for 10-20 gauge needles | +4544528100 | info@bkmedical.com |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 320626 | 1541997176 | K231764 | Ultrasound System 1300 | IYN | 2023-10-23 |
| 320626 | 1321973200 | K223830 | Ultrasound System 2300 | IYN | 2023-04-11 |
| 320626 | 1162425802 | K180737 | Ultrasound Scanner System bk2300 | IYN | 2018-08-01 |
| 320626 | 1398153879 | K173569 | Ultrasound System 1300 | IYN | 2018-02-23 |
| 320626 | 1914306904 | K132335 | ULTRASOUND SCANNER FLEX FOCUS 1202 | IYN | 2014-01-10 |
| 320626 | 1758208123 | K083667 | NEEDLE GUIDE FOR 8814, MODEL UA1335, NEEDLE GUIDE FOR 8815, MODEL UA 1336, NEEDLE GUIDE FOR 8824, MODEL UA 1337 | ITX | 2009-02-02 |
| 320626 | 1145940747 | K081323 | BIOPSY GUIDE KIT FOR 8808 AND BIPLANE, ENDFIRE AND DUAL BIOPSY GUIDES FOR 8818 | FCG | 2008-07-22 |
Product Codes Associated With Registrations#
PMN#
Ultrasound System 2300
Bk Medical Aps
Ultrasound System 2300
BK Medical Aps
Ultrasound Scanner System Bk2300
BK Medical ApS
Ultrasound System 1300
BK Medical ApS
Bk2300
BK MEDICAL APS
Ultrasound Scanner System BK2300
BK MEDICAL APS
Ultrasound Scanner System Bk2300
BK MEDICAL APS
Ultrasound Scanner System Bk2300
BK MEDICAL APS
GUDID#
Single-Use Biopsy guide - Sterile packed. Bore diameter 2.1 mm; angle of insertion 17.7° to the long axis of the transducer
2016-09-17
Extended, Single-Use Biopsy Guide - Sterile-packed. Extended. Bore diameter 1.6mm; angle of insertion 17.7° to the long axis of the transducer
2016-09-17
Single-Use Biplane Biopsy Guide - Sterile packed. Bore diameter 1.6 mm; angle of insertion 19° to the long axis of the transducer
2016-09-17
Single-Use Biplane Biopsy Guide - Sterile packed. Bore diameter 2.1 mm; angle of insertion 19° to the long axis of the transducer
2016-09-17
Single-Use Endfire Biopsy Guide - Sterile-packed. Bore diameter 1.6 mm; angle of insertion 0° to the long axis of the transducer
2016-09-17
Single-Use Dual Biopsy Guide - Sterile packed. Bore diameter 1.6 mm; angle of insertion 0° and 19° to the long axis of the transducer
2016-09-17
Single-Use Needle Guide - Sterile packed. Accepts needles 10-20 gauge; angle of insertion 30° to the image axis
2016-09-17
Single-Use Needle Guide - Sterile-packed. Includes: 3-angle insert for 10-20 gauge needles (9 pcs), free-angle insert for 10-20 gauge needles
2016-09-17
Single-Use Needle Guide - Sterile packed. Includes 2 needle guide insert palettes (3-angle and free-angle respectively), each with 9 different inserts for 10-20 gauge needles
2016-09-17
Single-Use Needle Guide - Sterile packed. Includes: 4 free-angle in-plane inserts, 4 out-of-plane 4-channel inserts and 4 out-of-plane free-angle inserts for 14-22 gauge needles
2016-09-17
Single Use Needle Guide - Sterile-packed. Bore diameter 1.6 mm; angle of insertion 0° to the long axis of the transducer
2016-12-09
Disposable Needle Guide - Disposable needle guide for 5C1e (9085)
2025-04-30
Single-Use Needle Guide - Sterile packed. Includes 2 needle guide insert palettes (3-angle and free-angle respectively), each with 9 different inserts for 10-20 gauge needles
2016-09-17
Single-Use Needle Guide - Sterile packed. Includes 1 needle guide palette and 9 different inserts for 10-20 gauge needles
2016-09-17
Non-implantable needle guide, single-use - UA1353-SIP
2022-12-07
Foot Switch - USB Foot Switch for bk3000, bk5000, bkActiv
2025-05-07
Wireless Remote Control - Wireless Remote Control for bk3000 and bk5000
2025-05-07
Wireless Remote Control - Wireless Remote Control for bkActiv
2025-05-07
Water Standoff Collar - Water Standoff Collar for 20R3 / 9052 Transducer
2025-04-30
Rectosigmoidoscope with Obturator - Rectosigmoidoscope with obturator, compatible with Welch Allyn Light Source for 20R3 / 9052
2025-04-30
Rectosigmoidoscope with Obturator - Rectosigmoidoscope with obturator, compatible with Storz Light Source for 20R3 / 9052
2025-04-30
Dummy Channel Bracket - Dummy Channel Bracket for 8808e, 8818
2025-04-30
Dummy Channel Bracket - Dummy Channel Bracket for 9008, 9018
2025-04-30
I13C3fx Transducer - Tracked Laparoscopic Intraoperative Transducer -withbuild-in tracking internal sensor
2023-06-14
Non-implantable needle guide, single-use - Disposable 18g Transperineal Needle Guide
2022-12-07
Rob12C4 - The Rob12C4 drop-in transducer enables unique access to complex organs and difficult-to-access anatomy during robotic-assisted procedures.
2022-05-23
I13C3f Transducer - Intraoperative
2020-03-26
N20P6 Transducer - High resolution, mini footprint, Intraoperative (neuro) imaging
2020-03-26
I12C5 transducer - Peripheral vessel (vascular), Pediatric, Small organs (small parts), Musculoskeletal (conventional and superficial)
2020-03-26
Non-implantable, needle guide, reusable - Reusable Transperineal Needle Guide
2019-09-19
Non-implantable, needle guide, reusable - Reusable Needle Guide
2019-09-19
Non-implantable, needle guide, reusable - Reusable Needle Guide
2019-09-19
Non-implantable, needle guide, reusable - Reusable Needle Guide
2019-09-19
Non-implantable, needle guide, reusable - Reusable Puncture Attachment
2019-09-19
Non-implantable, needle guide, reusable - Reusable Needle Guide
2019-09-19
Non-implantable, needle guide, reusable - Reusable Perineal Needle Guide
2019-09-19
Non-implantable, needle guide, reusable - Reusable Biplane Biopsy Guide
2019-09-19
Non-implantable, needle guide, reusable - Reusable Endfire Biopsy Guide
2019-09-19
Non-implantable, needle guide, reusable - Reusable Dual Biopsy Guide
2019-09-19
Non-implantable, needle guide, reusable - Reusable Needle Guide
2019-09-19