Pajunk GmbH Medizintechnologie
GEISINGEN Baden-Wurttemberg, DE
PAJUNK GMBH MEDIZINTECHNOLOGIE appears in FDA device records in GEISINGEN Baden-Wurttemberg, DE. FDA records list 63 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show one recall for this company, and at least one establishment registration is current.
FDA records held for this company
FDA records under these names
1 nameFDA records resolved to Pajunk GmbH Medizintechnologie carry these names as well, as FDA wrote them. Each is the firm named on a registration, a 510(k), a PMA, a recall or an enforcement report that was joined to this company on a shared FDA identifier or on a matching name.
- Pajunk GmbH510(k), enforcement report, recall
510(k) clearance history
Showing 50 of 63FDA records hold 63 510(k) clearances for Pajunk GmbH Medizintechnologie between 1991 and 2025. The busiest year on record is 2006, with 9. The most recent is 2025, with 4.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1991 | 1 |
| 1992 | 2 |
| 2000 | 1 |
| 2001 | 3 |
| 2002 | 1 |
| 2003 | 1 |
| 2004 | 5 |
| 2005 | 1 |
| 2006 | 9 |
| 2007 | 6 |
| 2008 | 6 |
| 2009 | 1 |
| 2011 | 2 |
| 2012 | 3 |
| 2016 | 5 |
| 2017 | 3 |
| 2018 | 1 |
| 2019 | 2 |
| 2020 | 1 |
| 2022 | 1 |
| 2023 | 2 |
| 2024 | 2 |
| 2025 | 4 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K243690 | SonoMSK | BSP | Substantially Equivalent | |
| K243682 | SonoPlex STIM; SonoPlex II | BSP | Substantially Equivalent | |
| K250774 | SPROTTE® STANDARD (LUER/ NRFit®) Lumbar Puncture | BSP | Substantially Equivalent | |
| K243525 | SonoTAP and SonoTAP II | BSP | Substantially Equivalent | |
| K241953 | SPROTTE® STANDARD (LUER/ NRFit®) Anesthesiology | BSP | Substantially Equivalent | |
| K241954 | SonoBlock; SonoBlock II | BSP | Substantially Equivalent | |
| K230701 | Stim2Go | IPF | Substantially Equivalent | |
| K230201 | Disposable Pre-calibrated Brain Biopsy Needle 2.0 | HAW | Substantially Equivalent | |
| K220897 | Disposable Brain Biopsy Needle 2.0 | HAW | Substantially Equivalent | |
| K202699 | E-Cath STIM acc. Tsui | CAZ | Substantially Equivalent | |
| K190663 | Epidural MiniFilter LUER 80369-7, Epidural MiniFilter NRFit 80369-6 | BSN | Substantially Equivalent | |
| K190345 | VPC | CAZ | Substantially Equivalent | |
| K172777 | Catheter Clamping Adapter LUER 80369-7, Catheter Clamping Adapter NRFit 80369-7 | BSO | Substantially Equivalent | |
| K170305 | Spinal Manometer NRFit; Spinal Manometer LUER | FMJ | Substantially Equivalent | |
| K170435 | NerveGuard NRFit, NerveGuard LUER | BSP | Substantially Equivalent | |
| K162086 | MultiStim ECO | BXN | Substantially Equivalent | |
| K160297 | Tuohy NRFit | BSP | Substantially Equivalent | |
| K160296 | SPROTTE SPECIAL NRFit | BSP | Substantially Equivalent | |
| K160295 | SPROTTE NRFit, Quincke NRFit | BSP | Substantially Equivalent | |
| K160294 | SPROTTE NRFit, Quincke NRFit Lumbar Puncture needles | BSP | Substantially Equivalent | |
| K152952 | E-Cath | BSO | Substantially Equivalent | |
| K113188 | SONOLONG SONO, CURL SONO, NANOLINE, BRAND NAMES CARRYINGSONO/SONOLONG | CAZ | Substantially Equivalent | |
| K113207 | SONO TAP, TUOHY SONO | BSP | Substantially Equivalent | |
| K113196 | VASCULAR SONO | DYB | Substantially Equivalent | |
| K113209 | CHIBA SONO | KNW | Substantially Equivalent | |
| K111374 | SONO-SERIES CORNERSTONE TECHNIQUE | BSP | Substantially Equivalent | |
| K090631 | PAJUNK DISPOSABLE BALLOONS AND BALLOON SYSTEMS | GCJ | Substantially Equivalent | |
| K082183 | PAJUNK'S GENERIC CONVENIENCE TRAY FOR REGIONAL ANESTHESIA: CSF | CAZ | Substantially Equivalent | |
| K082164 | PAJUNK'S GENERIC CONVENIENCE TRAY FOR REGIONAL ANESTHESIA OF THE PERIPHERAL PLEXUS: SINGLE SHOT | CAZ | Substantially Equivalent | |
| K080675 | PAJUNK INFILTRALONG WOUND INFILTRATION CATHETER KIT | BSO | Substantially Equivalent | |
| K080674 | PAJUNK'S PRIMOCUT DISPOSABLE BIOPSY SYSTEM | MJG | Substantially Equivalent | |
| K080654 | PAJUNK'S KIT FOR BALLOON AIDED LAPAROSCOPY | GCJ | Substantially Equivalent | |
| K063350 | DUAL-CANNULA SYSTEM ACC. MANCAO, SPECIAL SPROTTE | BSP | Substantially Equivalent | |
| K062902 | PAJUNKS EPILONG SET PEDIATRIC | CAZ | Substantially Equivalent | |
| K063233 | DELTACUT (APPARATUS AND CANNULA) | KNW | Substantially Equivalent | |
| K070179 | TROKABONE, TROKABONE STERNAL | FCG | Substantially Equivalent | |
| K063697 | SPECIAL SPROTTE, CHIBA, DR STEINHOFF KIT | KNW | Substantially Equivalent | |
| K063528 | TROCASYS | GCJ | Substantially Equivalent | |
| K062900 | PAJUNKS STIMULONG TSUI-METHOD SET | CAZ | Substantially Equivalent | |
| K061172 | PAJUNK MULTISTIM SENSOR NERVE STIMULATORS | BXN | Substantially Equivalent | |
| K062097 | VERESS CANNULA AND MODULAR VERESS CANNULA | HET | Substantially Equivalent | |
| K062047 | ADAPTABLE MONOPOLAR ADAPTABLE AND/OR RETRACTABLE ELECTRODES | GEI | Substantially Equivalent | |
| K062072 | PAJUNKS DISPOSABLE INSERTS FOR HANDLE INSTRUMENTS AND HF ELECTRODES | GEI | Substantially Equivalent | |
| K060397 | RF LESION CANNULA, RF THERMOLESION CANNULA, THERMOLESION CANNULA, X-RAY CONTRAST CANNULA, CANNULA, FACET DENERATION NEED | GXI | Substantially Equivalent | |
| K060808 | BRAINPRO, BRAINPRO ACCESS | HAW | Substantially Equivalent | |
| K060311 | EPILONG KIT FOR ANESTHESIOLOGY | CAZ | Substantially Equivalent | |
| K060563 | EPISPIN, EPISPIN II SAFETY, EPISPIN II, EPISPIN I, EPISPIN IV | CAZ | Substantially Equivalent | |
| K053283 | UNIPLEX NANOLINE CANNULA, PLEXOLONG NANOLINE SET, STIMULONG NANOLINE SET | CAZ | Substantially Equivalent | |
| K053282 | ADAPTABLE MONOPOLAR ELECTRODES WITH CERAMIC TIP | GEI | Substantially Equivalent | |
| K043130 | MODIFICATION TO PAJUNK STIMULONG PLUS CATHETER SETS | CAZ | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 9611612 | 3002807847 | PAJUNK GMBH MEDIZINTECHNOLOGIE | KARL-HALL-STRASSE 01, GEISINGEN Baden-Wurttemberg 78187 DE | 2026 | and 24 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- MRZAccessories, Pump, Infusion
- CAZAnesthesia Conduction Kit
- FCGBiopsy Needle
- HMXCannula, Ophthalmic
- BSOCatheter, Conduction, Anesthetic
- OGDCustom Anesthesia Tray
- HCCDevice, Biofeedback
- MJGDevice, Percutaneous, Biopsy
- GEIElectrosurgical, Cutting & Coagulation & Accessories
- OGEEpidural Anesthesia Kit
- BSNFilter, Conduction, Anesthetic
- GXDGenerator, Lesion, Radiofrequency
- GDFGuide, Needle, Surgical
- GDZHandle, Scalpel
- HIHHysteroscope (And Accessories)
- KNWInstrument, Biopsy
- MDMInstrument, Manual, Surgical, General Use
- KDCInstrument, Surgical, Disposable
- DYBIntroducer, Catheter
- GCJLaparoscope, General & Plastic Surgery
- HETLaparoscope, Gynecologic (And Accessories)
- FMJManometer, Spinal-Fluid
- BSPNeedle, Conduction, Anesthetic (W/Wo Introducer)
- HAWNeurological Stereotaxic Instrument
- GXIProbe, Radiofrequency Lesion
- OFUSpinal Anesthesia Kit
- IPFStimulator, Muscle, Powered
- BXNStimulator, Nerve, Battery-Powered
- GZJStimulator, Nerve, Transcutaneous, For Pain Relief
- GZIStimulator, Neuromuscular, External Functional
- EICSyringe, Periodontic, Endodontic, Irrigating
- IWJSystem, Applicator, Radionuclide, Manual
- KGXTape And Bandage, Adhesive
- FGBUreteroscope And Accessories, Flexible/Rigid
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-0234-2020 | SPROTTE Lumbar with Introducer, labeled as the following: 1. Sprotte 22G x 90mm w/ introducer and wings (25/box); 2. Sprotte 22G x 120mm w/ introducer and wings (25/box); 3. Sprotte 19G x 90mm w/ introducer and wings (25/box]); 4. Sprotte 22G x 103mm w/ introducer and wings (25/box); 5. Sprotte 21G x 90mm w/ introducer and wings (25/box); 6. Sprotte 21G x 103mm w/ introducer and wings (25/box); 7. Sprotte 20G x 103mm w/ introducer and wings (25/box); 8. Sprotte 20G x 90mm w/ introducer and wings (25/box) Product Usage: The SPROTTE lumbar puncture needles are intended to gain entry into or puncture the spinal cavity permitting injection (including anesthesia) / withdrawal of fluids for purposes of diagnostic lumbar puncture, myelography/ discography procedures. The device is intended for adult and pediatric patients. | Problem with packaging sealing process which affects sterility. | Class II | Open, Classified |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain