Pajunk GmbH: FDA clearances and approvals
Pajunk GmbH has 19 FDA 510(k) clearances (first 1991, latest 2012), across 6 product codes in 2 review panels. Median 510(k) review time: 121 days. openFDA lists 1 product recall by a recalling firm named Pajunk GmbH.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 1 | 121 |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| BSP | Needle, Conduction, Anesthetic (W/Wo Introducer) | 8 | 8 |
| CAZ | Anesthesia Conduction Kit | 5 | 5 |
| GCJ | Laparoscope, General & Plastic Surgery | 3 | 3 |
| BXN | Stimulator, Nerve, Battery-Powered | 1 | 1 |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | 1 | 1 |
| KNW | Instrument, Biopsy | 1 | 1 |
Review panels
Most recent Pajunk GmbH 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K113207 | SONO TAP, TUOHY SONO | BSP | 2012-02-29 | 121 |
| K113209 | CHIBA SONO | KNW | 2011-11-21 | 21 |
| K060563 | EPISPIN, EPISPIN II SAFETY, EPISPIN II, EPISPIN I, EPISPIN IV | CAZ | 2006-06-02 | 114 |
| K053283 | UNIPLEX NANOLINE CANNULA, PLEXOLONG NANOLINE SET, STIMULONG NANOLINE SET | CAZ | 2006-01-12 | 48 |
| K053282 | ADAPTABLE MONOPOLAR ELECTRODES WITH CERAMIC TIP | GEI | 2005-12-13 | 18 |
| K043130 | MODIFICATION TO PAJUNK STIMULONG PLUS CATHETER SETS | CAZ | 2004-12-21 | 39 |
| K042979 | MODIFICATION TO: PLEXALONG SETS | BSP | 2004-12-21 | 53 |
| K040965 | PAJUNK TUOHY NEEDLES, QUINCKE NEEDLES, CHIBA NEEDLES & CRAWFORD NEEDLES | BSP | 2004-09-07 | 146 |
| K033018 | STIMULONG PLUS CATHETER SET MODEL, VARIOUS | CAZ | 2004-05-05 | 222 |
| K033249 | PAJUNK MODULAR HANDLE INSTRUMENTS | GCJ | 2004-03-05 | 150 |
9 earlier clearances. See the full list in Caduvo.
Recalls
1 product recalls in 1 recall events; 0 initiated in the last five years. Most recent: 2019-08-30.
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Pajunk GmbH have?
Pajunk GmbH has 19 FDA 510(k) clearances (first 1991, latest 2012), across 6 product codes in 2 review panels.
How long does FDA take to clear Pajunk GmbH's 510(k)s?
The median time from FDA receipt to decision across Pajunk GmbH's cleared 510(k)s is 121 days.
What devices does Pajunk GmbH make?
Its most frequent FDA product codes are BSP (Needle, Conduction, Anesthetic (W/Wo Introducer), 8); CAZ (Anesthesia Conduction Kit, 5); GCJ (Laparoscope, General & Plastic Surgery, 3).
Has Pajunk GmbH had device recalls?
openFDA lists 1 product recall in 1 recall event by a recalling firm whose name matches Pajunk GmbH; the most recent began 2019-08-30. Recall firm names are matched by name, so related entities filing under other names are not included.
Next steps
- See all 19 Pajunk GmbH clearances with predicates and recalls
- Run predicate analysis for product code BSP, Pajunk GmbH's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.