510(k) K133316
- Device
- SPIROL BLOCK (19 GA. OPEN END MODELS), (20 GA. OPEN END MODELS), (19 GA. CLOSED END MODELS), (20 GA. CLOSED END MODELS)
- Applicant
- EPIMED INTERNATIONAL, INC.
- 510(k) number
- K133316
- Product code
- BSO
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2014-05-28
- Date received
- 2013-10-28
- Regulation
- 868.5120
- Classification name
- Catheter, Conduction, Anesthetic
- Medical specialty
- Anesthesiology
- Review panel
- Anesthesiology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- PRESTON H FRASIER
- Address
- 141 Sal Landrio Dr. Crossroads Business Park Johnstown NY US 12095 12095
FDA Registration Numbers#
- 9680425
- 2521402
- 9680794
- 3011137372
- 2523676
- 2020735
- 9617604
- 3009039068
- 3009746061
- 3011270181
- 1061124
- 1417592
- 3003767927
- 3012307300
- 1644312
- 2243072
- 1000563940
- 3010041511
- 3016761372
- 1319639
- 1643059
- 3010170586
- 3004893332
- 3013162291
- 3021006165
- 9610825
- 2029275
- 3015460875
- 3004784537
- 9611612
- 3006188722
- 1018470
- 3010321647
- 3003898360
- 3015859709
- 3014656749
- 3007441619
- 3016678045
- 1043214
- 1643817
- 2030624
- 3003915875
- 3006946348
- 2134812
- 3015443199
- 3009599228
- 3013764800
- 2618282
- 3006425876
- 3002806603
- 3009888344
- 3015972753
- 3004365956
- 1316297
- 1423507
Source Documents#
Other 510(k) Records For Product Code BSO #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K241410 | EDEN ControlCath | Jmt Co., Ltd. | 2025-02-13 |
| K231242 | Perifix FX Catheter; Contiplex FX Catheter | B.Braun Medical, Inc. | 2023-09-15 |
| K230603 | Arrow Non-Stimulating SnapLock Adapter (K-05520-005C); Arrow Non-Stimulating Next Gen SnapLock Adapter (Luer Connection) (CA-000010-19); Arrow Non-Stimulating Next Gen SnapLock Adapter (Neuraxial Connection) (CA-000014-19); Arrow Stimulating SnapLock Adapter (with cable) (TZ-02060-001); Arrow Stimulating SnapLock Adapter (with tab) (TZ-05000-002) | Teleflex Medical | 2023-08-30 |
| K193664 | SubQKath Catheter and Needle Set | Hk Surgical | 2020-09-09 |
| K200624 | Percutaneous Introducer | Epimed International, Inc. | 2020-04-27 |
| K191470 | C-CAT Anaesthesia Catheter kit | Cimpax Aps | 2019-10-25 |
| K181782 | Medline Reinforced Epidural Catheter | Medline Industries, Inc. | 2019-03-04 |
| K173541 | EPINAUT | Imedicom Co., Ltd. | 2018-08-24 |
| K172777 | Catheter Clamping Adapter LUER 80369-7, Catheter Clamping Adapter NRFit 80369-7 | PAJUNK GmbH Medizintechnologie | 2018-05-03 |
| K171584 | B. Braun Tear-Away Introducer Needle | B.Braun Medical, Inc. | 2017-12-22 |
| K171193 | Certa Catheter | Ferrosan Medical Devices Sp. Z.O.O. | 2017-12-18 |
| K162522 | UltraCath Continuous Nerve block Catheter | Teleflexmedical, Inc. | 2017-03-17 |
| K161232 | ON-Q* EchoSpark Echogenic Catheter; ON-Q* T-bloc* Echogenic Continuous Nerve Block Kit | Halyard Health | 2016-09-30 |
| K153297 | Perifix and Contiplex Catheter | B.Braun Medical, Inc. | 2016-08-12 |
| K152952 | E-Cath | PAJUNK GmbH Medizintechnologie | 2016-07-13 |
Legacy Summary#
summary
FDA Review#
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