Mini Lap Technologies, Inc.: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Mini Lap Technologies, Inc.” (first 2007, latest 2010), across 3 product codes in 2 review panels. Median 510(k) review time under this name: 94 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 |
|---|---|---|---|
| OCW | Endoscopic Tissue Approximation Device | 3 | 3 |
| GCJ | Laparoscope, General & Plastic Surgery | 1 | 1 |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | 1 | 1 |
Review panels
Most recent Mini Lap Technologies, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K101101 | MINI-TONG | OCW | 2010-07-23 | 94 |
| K093449 | MINI LAP RETRACTORS | GCJ | 2010-02-12 | 99 |
| K083754 | MINI LAP ELECTROCAUTERY INSTRUMENTS | GEI | 2009-11-20 | 338 |
| K070686 | MINI LAP INSTRUMENTS | OCW | 2007-04-05 | 24 |
| K070352 | MINI LAP PEDIATRIC INSTRUMENTS WITH MEDUSA CLAMPING SYSTEM | OCW | 2007-04-05 | 58 |
Recalls
openFDA lists no recalls under a recalling firm named Mini Lap Technologies, Inc..
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.
- Mini-Mitter Co., Inc. (5 510(k)s)
- Mini Floss (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Mini Lap Technologies, Inc.?
FDA lists 5 510(k) clearances under the applicant name “Mini Lap Technologies, Inc.” (first 2007, latest 2010), across 3 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 Mini Lap Technologies, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Mini Lap Technologies, Inc. is 94 days.
Which FDA product codes appear under Mini Lap Technologies, Inc.?
The most frequent FDA product codes under this applicant name are OCW (Endoscopic Tissue Approximation Device, 3); GCJ (Laparoscope, General & Plastic Surgery, 1); GEI (Electrosurgical, Cutting & Coagulation & Accessories, 1).
Next steps
- See all 5 Mini Lap Technologies, Inc. clearances with predicates and recalls
- Run predicate analysis for product code OCW, Mini Lap Technologies, Inc.'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 (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.