FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
StimuQuik 21G x 9cm (3.5) Peripheral Nerve Block Needle, StimuQuik Echo 21G x 9cm (3.5) Peripheral Nerve Block Needle, StimuQuik 21G x 15cm (6) Peripheral Nerve Block Needle, StimuQuik Echo 21G x 15cm (6) Peripheral Nerve Block Needle, StimuQuik 21G x 2.5cm (1) Peripheral Nerve Block Needle
K Number: K173321
·
Decision Apr 25, 2018
Classifications
1
FEI Numbers
136
Registration Numbers
136
Same Product Code
151
Applicant Total
39
Review Days
187
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- StimuQuik 21G x 9cm (3.5) Peripheral Nerve Block Needle, StimuQuik Echo 21G x 9cm (3.5) Peripheral Nerve Block Needle, StimuQuik 21G x 15cm (6) Peripheral Nerve Block Needle, StimuQuik Echo 21G x 15cm (6) Peripheral Nerve Block Needle, StimuQuik 21G x 2.5cm (1) Peripheral Nerve Block Needle
- K Number
- K173321
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.5150
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Teleflex Medical
- Date Received
- October 20, 2017
- Decision Date
- April 25, 2018
- Product Code
- BSP
- Advisory Committee
- Anesthesiology
- Review Advisory Committee
- AN
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| BSP | Needle, Conduction, Anesthetic (W/Wo Introducer) | FDA class 2 | Anesthesiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (BSP), ordered by most recent decision date.
SonoMSK
FDA 510(k)
FDA Class 2
·Anesthesiology
SonoPlex STIM; SonoPlex II
FDA 510(k)
FDA Class 2
·Anesthesiology
SPROTTE® STANDARD (LUER/ NRFit®) Lumbar Puncture
FDA 510(k)
FDA Class 2
·Anesthesiology
SonoTAP and SonoTAP II
FDA 510(k)
FDA Class 2
·Anesthesiology
SPROTTE® STANDARD (LUER/ NRFit®) Anesthesiology
FDA 510(k)
FDA Class 2
·Anesthesiology
SonoBlock; SonoBlock II
FDA 510(k)
FDA Class 2
·Anesthesiology
Other Clearances by Teleflex Medical
| K Number | Device Name | ||
|---|---|---|---|
| K251054 | Hem-o-lok PurplePlus Large Polymer Ligating Clips | Jul 3, 2025 | Substantially Equivalent |
| K242495 | LMA Fastrach ETT SU | Apr 29, 2025 | Substantially Equivalent |
| K243553 | QuikClot Control+ Hemostatic Device | Mar 18, 2025 | Substantially Equivalent |
| K241784 | Arrow® Nitinol Wire | Sep 18, 2024 | Substantially Equivalent |
| K233713 | Pilling Tracheostomy Tubes | Mar 22, 2024 | Substantially Equivalent |
| K232970 | Hem-o-lok® Ligating Clips | Jan 12, 2024 | Substantially Equivalent |
| 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) | Aug 30, 2023 | Substantially Equivalent |
| K231924 | EZ-IO Intraosseous Vascular Access System | Jul 25, 2023 | Substantially Equivalent |
| K230480 | Weck Auto Endo5 5mm Automatic Endoscopic 35cm Applier (AE05ML) | Apr 28, 2023 | Substantially Equivalent |
| K222279 | Rusch Intermittent Urethral Catheters | Aug 29, 2022 | Substantially Equivalent |