Atlas FDA

MODIFICATION TO PLEXOLONG SETS

FDA 510(k) clearance K023218 · decided 2003-03-24

Clearance details

K-number
K023218
Device name
MODIFICATION TO PLEXOLONG SETS
Applicant
Pajunk GmbH
Decision
Substantially Equivalent
Date received
2002-09-26
Decision date
2003-03-24
Days to decision
179 days
Clearance type
Special
Product code
BSP
Device class
2
Regulation number
868.5150
Medical specialty
Anesthesiology
Advisory committee
Anesthesiology
Location
Corvallis, OR, US
Third-party review
No
Expedited review
No

+ Add to Predicate Builder ◉ Watch Pajunk GmbH

Need this as data, not a web page?

Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.

Similar devices under this product code

Devices cleared under the same product code - the starting set for predicate research.

RecordFirmDate
SonoMSK (K243690)PAJUNK GmbH Medizintechnologie2025-07-01
SonoPlex STIM; SonoPlex II (K243682)PAJUNK GmbH Medizintechnologie2025-06-27
SPROTTE® STANDARD (LUER/ NRFit®) Lumbar Puncture (K250774)PAJUNK GmbH Medizintechnologie2025-06-25
SonoTAP and SonoTAP II (K243525)PAJUNK GmbH Medizintechnologie2025-03-24
SPROTTE® STANDARD (LUER/ NRFit®) Anesthesiology (K241953)PAJUNK GmbH Medizintechnologie2024-11-22
SonoBlock; SonoBlock II (K241954)PAJUNK GmbH Medizintechnologie2024-09-11
Reach Needle (K240253)Aerin Medical, Inc.2024-03-21
Medispine - Spinal Needle, Glospine - Spinal Needle (K212982)Global Medikit Limited2022-07-29
BD Perisafe Tuohy Epidural Needle, BD Perisafe Weiss Epidural Needle (K211085)Becton, Dickinson and Company2022-07-01
BD Quincke Spinal Needle, BD Whitacre Spinal Needle, BD Spinal Introducer Needle (K210978)Becton, Dickinson and Company2021-12-22
RELI NRFit Epidural Needles, Phoenix NRFit Epidural Needles, RELI NRFit Spinal Needles, Phoenix NRFit Spinal Needles (K203668)Myco Medical Supplies, Inc.2021-09-29
DiscCath Needle Set (K212328)Disccath, LLC2021-09-26

Recalls involving this device

No recalls on record reference this clearance.