Interscope, Inc.: FDA filings under this applicant name
FDA lists 3 510(k) clearances under the applicant name “Interscope, Inc.” (first 2017, latest 2019), plus 1 De Novo decision, across 3 product codes in 2 review panels. Median 510(k) review time under this name: 248 days. Since 2017 the median was 248 days, against 149 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 |
|---|---|---|
| 2017 | 1 | 95 |
| 2018 | 0 | — |
| 2019 | 2 | 258 |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Interscope, Inc. took a median 248 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 149 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| PTE | Endoscopic Morcellator Gastroenterology | 2 | 2 |
| ERL | Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece | 1 | 1 |
| QNE | Endoscopic Pancreatic Debridement Device | 1 | 0 |
Review panels
Most recent Interscope, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K190715 | EndoRotor Console, EndoRotor Catheter, EndoRotor Specimen Trap, EndoRotor Filter Set, EndoRotor Roll Stand | ERL | 2019-12-13 | 269 |
| K181127 | EndoRotor Console, EndoRotor Catheters, EndoRotor Specimen Trap, EndoRotor Filter Set, EndoRotor Foot Control | PTE | 2019-01-03 | 248 |
| K170120 | EndoRotor | PTE | 2017-04-18 | 95 |
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| DEN200016 | De Novo | Endoscopic Pancreatic Debridement Device | 2020-12-23 |
Recalls
openFDA lists no recalls under a recalling firm named Interscope, 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.
Device clinical trials
An industry sponsor named Interscope, Inc. is the lead sponsor of 2 device studies on ClinicalTrials.gov (0 active or recruiting). Most recent:
- NCT03694210: EndoRotor DEN (Direct Endoscopic Necrosectomy)Trial (Completed, started 2018-11-15)
- NCT04203667: EndoRotor® Endoscopic Mucosal Resection System for the Colon (Completed, started 2018-04-18)
Frequently asked questions
How many FDA 510(k) clearances are listed under Interscope, Inc.?
FDA lists 3 510(k) clearances under the applicant name “Interscope, Inc.” (first 2017, latest 2019), plus 1 De Novo decision, 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 Interscope, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Interscope, Inc. is 248 days. Since 2017: 248 days, versus 149 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Interscope, Inc.?
The most frequent FDA product codes under this applicant name are PTE (Endoscopic Morcellator Gastroenterology, 2); ERL (Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece, 1); QNE (Endoscopic Pancreatic Debridement Device, 1).
Next steps
- See all 3 Interscope, Inc. clearances with predicates and recalls
- Run predicate analysis for product code PTE, Interscope, 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.