Mectra Labs, Inc.: FDA clearances and approvals
Mectra Labs, Inc. has 9 FDA 510(k) clearances (first 1992, latest 2012), across 5 product codes in 3 review panels. Median 510(k) review time: 139 days.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 1 | 255 |
| 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 |
|---|---|---|---|
| HIF | Insufflator, Laparoscopic | 3 | 3 |
| GCJ | Laparoscope, General & Plastic Surgery | 2 | 2 |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | 2 | 2 |
| HIN | Coagulator-Cutter, Endoscopic, Bipolar (And Accessories) | 1 | 1 |
| OCT | Anti Fog Solution And Accessories, Endoscopy | 1 | 1 |
Review panels
Most recent Mectra Labs, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K113080 | TUBALGATOR | HIN | 2012-06-29 | 255 |
| K033880 | ELECTRO-LUBE | GEI | 2004-03-10 | 86 |
| K021247 | PNEUMOPERITONEUM INSUFFLATION NEEDLE | HIF | 2002-11-08 | 203 |
| K993604 | ENDOSCOPIC ANTI FOG DEVICE | OCT | 2000-03-03 | 130 |
| K955352 | SUCTION CAUTERY PROBE | GEI | 1996-04-05 | 136 |
| K934547 | MECTRA TROCAR | GCJ | 1994-02-18 | 149 |
| K935382 | GRASPERS | GCJ | 1994-02-15 | 99 |
| K925691 | INSUFFLATION TUBING | HIF | 1993-09-23 | 315 |
| K920959 | INSUFFLATOR, LAPAROSCOPIC | HIF | 1992-07-13 | 139 |
Recalls
openFDA lists no recalls under a recalling firm named Mectra Labs, Inc..
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 Mectra Labs, Inc. have?
Mectra Labs, Inc. has 9 FDA 510(k) clearances (first 1992, latest 2012), across 5 product codes in 3 review panels.
How long does FDA take to clear Mectra Labs, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Mectra Labs, Inc.'s cleared 510(k)s is 139 days.
What devices does Mectra Labs, Inc. make?
Its most frequent FDA product codes are HIF (Insufflator, Laparoscopic, 3); GCJ (Laparoscope, General & Plastic Surgery, 2); GEI (Electrosurgical, Cutting & Coagulation & Accessories, 2).
Has Mectra Labs, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Mectra Labs, Inc. Related entities may recall under other names.
Next steps
- See all 9 Mectra Labs, Inc. clearances with predicates and recalls
- Run predicate analysis for product code HIF, Mectra Labs, Inc.'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.