Microline Surgical, Inc.: FDA filings under this applicant name
FDA lists 8 510(k) clearances under the applicant name “Microline Surgical, Inc.” (first 2012, latest 2024), across 2 product codes in 2 review panels. Median 510(k) review time under this name: 127 days. Since 2017 the median was 116 days, against 121 days for all cleared 510(k)s in the same product codes. 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 | 1 | 38 |
| 2013 | 1 | 89 |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 3 | 219 |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 1 | 105 |
| 2021 | 0 | — |
| 2022 | 1 | 156 |
| 2023 | 0 | — |
| 2024 | 1 | 116 |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Microline Surgical, Inc. took a median 116 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 121 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | 6 | 6 |
| KCT | Sterilization Wrap Containers, Trays, Cassettes & Other Accessories | 2 | 2 |
Review panels
Most recent Microline Surgical, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K234147 | ReNew XR Handpiece, 25cm, with Reference Markings (3943M); ReNew XR Handpiece, 34cm, with Reference Markings (3941M); ReNew XR Handpiece, 42cm, with Reference Markings (3942M); ReNew XR Handpiece, Ratcheted, 25cm, with Reference Markings (3946M); ReNew XR Handpiece, Ratcheted, 34cm, with Reference Markings (3944M); ReNew XR Handpiece, Ratcheted, 42cm, with Reference Markings (3945M) | GEI | 2024-04-23 | 116 |
| K213127 | ReNew Disposable Scissor Tips | GEI | 2022-03-02 | 156 |
| K201884 | ReNew XR Handpiece, ReNew XR Handpiece 34cm, ReNew XR Handpiece 42cm, ReNew XR Handpiece 25cm, Ratcheted ReNew XR Handpiece 34cm | GEI | 2020-10-21 | 105 |
| K160706 | ReNew V Handpiece Laparoscopic Instruments | GEI | 2016-10-19 | 219 |
| K152745 | ReNew Sterilization Trays(Catalog #3708 and #3709) | KCT | 2016-05-12 | 232 |
| K152743 | M/L-10 CLIP APPLIER STERILIZATION TRAY (Catalog#3706) | KCT | 2016-02-08 | 138 |
| K124029 | MICROLINE FLEXIBLE LIGATING SHEARS | GEI | 2013-03-27 | 89 |
| K122086 | THERMAL LIGATING SHEARS | GEI | 2012-08-23 | 38 |
Recalls
10 product recalls in 7 recall events; 1 initiated in the last five years. Most recent: 2024-11-05.
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.
Device clinical trials
An industry sponsor named Microline Surgical, Inc. is the lead sponsor of 1 device studies on ClinicalTrials.gov (0 active or recruiting). Most recent:
- NCT05363813: Post-market Clinical Follow-up Study of Reusable Clip Applier Cartridge Devices for LAParoscopic Surgery (Completed, started 2022-10-17)
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.
- Microline Scientific (14 510(k)s)
- Microline Pentax, Inc. (12 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Microline Surgical, Inc.?
FDA lists 8 510(k) clearances under the applicant name “Microline Surgical, Inc.” (first 2012, latest 2024), across 2 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 Microline Surgical, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Microline Surgical, Inc. is 127 days. Since 2017: 116 days, versus 121 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Microline Surgical, Inc.?
The most frequent FDA product codes under this applicant name are GEI (Electrosurgical, Cutting & Coagulation & Accessories, 6); KCT (Sterilization Wrap Containers, Trays, Cassettes & Other Accessories, 2).
Next steps
- See all 8 Microline Surgical, Inc. clearances with predicates and recalls
- Run predicate analysis for product code GEI, Microline Surgical, 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, 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.