Power Medical Interventions, Inc.: FDA filings under this applicant name
FDA lists 22 510(k) clearances under the applicant name “Power Medical Interventions, Inc.” (first 2001, latest 2009), across 1 product code in 1 review panel. Median 510(k) review time under this name: 28 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 |
|---|---|---|---|
| GDW | Staple, Implantable | 22 | 22 |
Review panels
Most recent Power Medical Interventions, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K091215 | INTELLIGENT POWER UNIT, INTELLIGENT CONSOLE, INTELLIGENT DELIVERY SYSTEM, INTELLIGENT SURGICAL INSTRUMENT | GDW | 2009-05-18 | 21 |
| K083527 | INTELLIGENT ARTICULATING ENDOSCOPIC LINEAR CUTTER REVERSE WITH RELOADS | GDW | 2008-12-18 | 20 |
| K081826 | INTELLIGENT STRAIGHT AND ARTICULAR ENDOSCOPIC LINEAR CUTTERS, VASCULAR WITH RELOADS, MODELS I30V, I45V, 160V, IR30V | GDW | 2008-07-25 | 28 |
| K073001 | IDRIVES, IDRIVEC, IDRIVEF | GDW | 2007-12-18 | 55 |
| K073148 | IDRIVES, IDRIVEC, IDRIVEF WITH VASCULAR INDICATIONS | GDW | 2007-12-07 | 29 |
| K071708 | I45, I45S, I60, AND I60S | GDW | 2007-09-27 | 98 |
| K063746 | POWER EXTENDERS MODEL# PEC200, PES200,PES200S | GDW | 2007-01-12 | 25 |
| K063075 | NATURAL ORIFICE LINEAR CUTTER DIGITAL LOADING UNITS | GDW | 2006-11-02 | 27 |
| K061649 | POWER CIRCULAR STAPLER DIGITAL LOADING UNIT WITH AND WITHOUT SHEATH | GDW | 2006-09-01 | 80 |
| K052910 | POWER RIGHT ANGLE LINEAR CUTTER DIGITAL LOADING UNIT WITH RELOADS | GDW | 2005-11-07 | 21 |
12 earlier clearances. See the full list in Caduvo.
Recalls
5 product recalls in 3 recall events; 0 initiated in the last five years. Most recent: 2007-05-12.
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.
- Power Products, Inc.-Splintek (3 510(k)s)
- Power Analytics Corp. (1 510(k)s)
- Power Medical Devices, LLC (1 510(k)s)
- Power Plus Mobility (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Power Medical Interventions, Inc.?
FDA lists 22 510(k) clearances under the applicant name “Power Medical Interventions, Inc.” (first 2001, latest 2009), across 1 product code in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Power Medical Interventions, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Power Medical Interventions, Inc. is 28 days.
Which FDA product codes appear under Power Medical Interventions, Inc.?
The most frequent FDA product codes under this applicant name are GDW (Staple, Implantable, 22).
Next steps
- See all 22 Power Medical Interventions, Inc. clearances with predicates and recalls
- Run predicate analysis for product code GDW, Power Medical Interventions, 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.