Interlace Medical, Inc.: FDA filings under this applicant name
FDA lists 7 510(k) clearances under the applicant name “Interlace Medical, Inc.” (first 2008, latest 2011), across 2 product codes in 2 review panels. Median 510(k) review time under this name: 95 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
Caduvo groups this applicant name under Hologic, based on public ownership records.
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 |
|---|---|---|---|
| HIH | Hysteroscope (And Accessories) | 6 | 6 |
| GCJ | Laparoscope, General & Plastic Surgery | 1 | 1 |
Review panels
Most recent Interlace Medical, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K103741 | SURGISURE TISSUE REMOVAL SYSTEM | GCJ | 2011-03-02 | 69 |
| K102686 | MYOSURE ROD LENS SCOPE SEALS | HIH | 2010-10-15 | 28 |
| K100559 | MYOSURE HYSTEROSCOPIC TISSUE REMOVAL SYSTEM | HIH | 2010-03-30 | 29 |
| K091100 | MYOSURE HYSTEROSCOPIC TISSUE REMOVAL SYSTEM | HIH | 2009-10-23 | 190 |
| K091465 | MYOSURE ROD LENS HYSTEROSCOPE | HIH | 2009-08-21 | 95 |
| K081070 | INTERLACE MEDICAL OPERATIVE HYSTEROSCOPY SYSTEM | HIH | 2008-07-23 | 99 |
| K073690 | INTERLACE MEDICAL HYSTEROSCOPIC MORCELLATION SYSTEM | HIH | 2008-04-17 | 111 |
Recalls
openFDA lists no recalls under a recalling firm named Interlace Medical, 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.
Frequently asked questions
How many FDA 510(k) clearances are listed under Interlace Medical, Inc.?
FDA lists 7 510(k) clearances under the applicant name “Interlace Medical, Inc.” (first 2008, latest 2011), 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 Interlace Medical, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Interlace Medical, Inc. is 95 days.
Which FDA product codes appear under Interlace Medical, Inc.?
The most frequent FDA product codes under this applicant name are HIH (Hysteroscope (And Accessories), 6); GCJ (Laparoscope, General & Plastic Surgery, 1).
Next steps
- See all 7 Interlace Medical, Inc. clearances with predicates and recalls
- Run predicate analysis for product code HIH, Interlace Medical, 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.