Mahe-Medizintechnik: FDA filings under this applicant name
FDA lists 8 510(k) clearances under the applicant name “Mahe-Medizintechnik” (first 1993, latest 1994), across 6 product codes in 4 review panels. Median 510(k) review time under this name: 212 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 | 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 |
|---|---|---|---|
| GCJ | Laparoscope, General & Plastic Surgery | 3 | 3 |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | 1 | 1 |
| HET | Laparoscope, Gynecologic (And Accessories) | 1 | 1 |
| HFB | Forceps, Biopsy, Gynecological | 1 | 1 |
| LRC | Instrument, Ent Manual Surgical | 1 | 1 |
| LXH | Orthopedic Manual Surgical Instrument | 1 | 1 |
Review panels
Most recent Mahe-Medizintechnik 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K942821 | MAHE INSTRUMENTS | GEI | 1994-11-02 | 141 |
| K942819 | TROCAR WITH SHIELD | GCJ | 1994-08-23 | 70 |
| K933768 | COAGULATOR, LAPAROSCOPIC, LUNIPOLAR/ACCESSORIES | HET | 1994-06-27 | 333 |
| K933767 | FORCEPS, BIOPSY GYNECOLOGICAL INSTRU/BIOPSY | HFB | 1994-05-26 | 301 |
| K933770 | FORCEPS, ENT INSTR, ENT MANUAL SURG RETRACT/ALL TYPE | LRC | 1994-03-23 | 237 |
| K935442 | MAHE INSTRUMENTS | GCJ | 1994-03-14 | 122 |
| K933772 | PUNCH SURGICAL | LXH | 1994-02-01 | 187 |
| K925624 | MICROSURGICAL INSTRUMENTS | GCJ | 1993-07-22 | 258 |
Recalls
openFDA lists no recalls under a recalling firm named Mahe-Medizintechnik.
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.
Frequently asked questions
How many FDA 510(k) clearances are listed under Mahe-Medizintechnik?
FDA lists 8 510(k) clearances under the applicant name “Mahe-Medizintechnik” (first 1993, latest 1994), across 6 product codes in 4 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 Mahe-Medizintechnik?
The median time from FDA receipt to decision across 510(k)s cleared under the name Mahe-Medizintechnik is 212 days.
Which FDA product codes appear under Mahe-Medizintechnik?
The most frequent FDA product codes under this applicant name are GCJ (Laparoscope, General & Plastic Surgery, 3); GEI (Electrosurgical, Cutting & Coagulation & Accessories, 1); HET (Laparoscope, Gynecologic (And Accessories), 1).
Next steps
- See all 8 Mahe-Medizintechnik clearances with predicates and recalls
- Run predicate analysis for product code GCJ, Mahe-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.