Heinz Kurz GmbH Medizintechnik: FDA filings under this applicant name
FDA lists 14 510(k) clearances under the applicant name “Heinz Kurz GmbH Medizintechnik” (first 1997, latest 2013), across 5 product codes in 2 review panels. Median 510(k) review time under this name: 24 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 2 | 398 |
| 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 |
|---|---|---|---|
| ETB | Prosthesis, Partial Ossicular Replacement | 6 | 6 |
| MML | Weights, Eyelid, External | 3 | 3 |
| ETA | Replacement, Ossicular Prosthesis, Total | 2 | 2 |
| ETD | Tube, Tympanostomy | 2 | 2 |
| KHJ | Polymer, Ent Synthetic-Polyamide (Mesh Or Foil Material) | 1 | 1 |
Review panels
- Ear, Nose and Throat (11)
- Ophthalmic (3)
Most recent Heinz Kurz GmbH Medizintechnik 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K130512 | NITIFLEX STAPES PROSTHESIS, DETROIT PISTON, SKARZYNSKI PISTON, ROBERSON STAPES PROSTHESIS | ETB | 2013-12-02 | 278 |
| K112616 | NITIBOND STAPES PROSTHESIS, NITIPLAST STAPES PROSTHESIS | ETB | 2013-02-08 | 519 |
| K071150 | TROCAR VENTILATION TUBE/WITH TROCAR TIP, TROCAR HANDLE, MODEL 1015 074, 1015 076, 1015 075, 1015 077, W/ RETENTION WIRE | ETD | 2007-12-12 | 231 |
| K042503 | KURZ CLIP PISTON MVP, MODEL 1006 711-13/0.4 MM + 1006 761-63/0.6MM | ETA | 2004-10-01 | 16 |
| K033796 | KURZ SILICONE STRIPS, MODELS SF-1, SF-1W, SF-1 BS | KHJ | 2004-01-30 | 56 |
| K021479 | CLIP PISTON AWENGEN, MODEL# 1006 805 - 1006 861 | ETB | 2002-05-21 | 13 |
| K013573 | CLIP PARTIAL PROSTHESIS-TITANIUM DRESDEN, MODEL 1002 250-257 | ETB | 2001-11-09 | 11 |
| K011115 | KURZ UPPER EYELID IMPLANT- PLATINUM/IRIDIUM,MODELS REGULAR 4007 003-007, SPECIAL 4007 002, 4007 008-010 | MML | 2001-05-02 | 20 |
| K002221 | KURKZ K-PISTON TITANIUM STAPEDIAL PROSTHESIS, MODEL 1006 103-1006 170 | ETB | 2000-08-09 | 16 |
| K001123 | KURZ UPPER EYELID IMPLANT SIZERS, MODEL 8000 111 | MML | 2000-04-21 | 14 |
4 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: 2011-04-27.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Heinz Kurz (5 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Heinz Kurz GmbH Medizintechnik?
FDA lists 14 510(k) clearances under the applicant name “Heinz Kurz GmbH Medizintechnik” (first 1997, latest 2013), across 5 product codes in 2 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Heinz Kurz GmbH Medizintechnik?
The median time from FDA receipt to decision across 510(k)s cleared under the name Heinz Kurz GmbH Medizintechnik is 24 days.
Which FDA product codes appear under Heinz Kurz GmbH Medizintechnik?
The most frequent FDA product codes under this applicant name are ETB (Prosthesis, Partial Ossicular Replacement, 6); MML (Weights, Eyelid, External, 3); ETA (Replacement, Ossicular Prosthesis, Total, 2).
Next steps
- See all 14 Heinz Kurz GmbH Medizintechnik clearances with predicates and recalls
- Run predicate analysis for product code ETB, Heinz Kurz GmbH Medizintechnik's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.