Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Power Medical Interventions, Inc. — Predicate Candidate Screening
22 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
29 daysmedian FDA review time
80 days90th percentile
22clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K091215 | INTELLIGENT POWER UNIT, INTELLIGENT CONSOLE, INTELLIGENT DEL | Power Medical Interventions, Inc. | 2009-05-18 | 21 | 1 |
| K083527 | INTELLIGENT ARTICULATING ENDOSCOPIC LINEAR CUTTER REVERSE WI | Power Medical Interventions, Inc. | 2008-12-18 | 20 | 1 |
| K081826 | INTELLIGENT STRAIGHT AND ARTICULAR ENDOSCOPIC LINEAR CUTTERS | Power Medical Interventions, Inc. | 2008-07-25 | 28 | 1 |
| K073001 | IDRIVES, IDRIVEC, IDRIVEF | Power Medical Interventions, Inc. | 2007-12-18 | 55 | 1 |
| K073148 | IDRIVES, IDRIVEC, IDRIVEF WITH VASCULAR INDICATIONS | Power Medical Interventions, Inc. | 2007-12-07 | 29 | 0 |
| K071708 | I45, I45S, I60, AND I60S | Power Medical Interventions, Inc. | 2007-09-27 | 98 | 1 |
| K063746 | POWER EXTENDERS MODEL# PEC200, PES200,PES200S | Power Medical Interventions, Inc. | 2007-01-12 | 25 | 0 |
| K063075 | NATURAL ORIFICE LINEAR CUTTER DIGITAL LOADING UNITS | Power Medical Interventions, Inc. | 2006-11-02 | 27 | 0 |
| K061649 | POWER CIRCULAR STAPLER DIGITAL LOADING UNIT WITH AND WITHOUT | Power Medical Interventions, Inc. | 2006-09-01 | 80 | 0 |
| K052910 | POWER RIGHT ANGLE LINEAR CUTTER DIGITAL LOADING UNIT WITH RE | Power Medical Interventions, Inc. | 2005-11-07 | 21 | 0 |
| K052415 | POWER LINEAR CUTTER REUSABLE DIGITAL LOADING UNITS WITH RELO | Power Medical Interventions, Inc. | 2005-09-29 | 27 | 1 |
| K040720 | SURGASSIST COMPUTER MEDIATED LINEAR CUTTER DIGITAL LOADING U | Power Medical Interventions, Inc. | 2004-06-03 | 76 | 1 |
| K040398 | SURGASSIST STRAIGHT LINEAR 4 ROW NO KNIFE DLUS WITH RELOADS | Power Medical Interventions, Inc. | 2004-03-24 | 36 | 0 |
| K040024 | SURGASSIST CIRCULAR STAPLER DIGITAL LOADING UNITS - 29 MM, M | Power Medical Interventions, Inc. | 2004-02-04 | 28 | 1 |
| K032701 | SURGASSIST CIRCULAR STAPLER DIGITAL LOADING UNITS (CS21, CS2 | Power Medical Interventions, Inc. | 2003-09-30 | 28 | 3 |
| K030653 | SURGASSIST STRAIGHT LINEAR STAPLER AND STRAIGHT LINEAR 4 ROW | Power Medical Interventions, Inc. | 2003-03-31 | 28 | 0 |
| K022313 | SURGASSIST RIGHT ANGLE LINEAR CUTTER DLU 30MM, 45MM & 60MM - | Power Medical Interventions, Inc. | 2002-12-09 | 145 | 0 |
| K021701 | SURGASSIST RIGHT ANGLE LINEAR CUTTER 30MM, 45MM & 60MM, MODE | Power Medical Interventions, Inc. | 2002-06-21 | 29 | 1 |
| K021249 | SURGASSIST FLEXSHAFT 2, MODEL FS2 14 | Power Medical Interventions, Inc. | 2002-05-15 | 26 | 1 |
| K020719 | SURGASSIST SYSTEM STRAIGHT LINEAR CUTTER DIGITAL LOADING UNI | Power Medical Interventions, Inc. | 2002-05-10 | 66 | 1 |
| K020343 | SURGASSIST SYSTEM; WIRELESS REMOTE CONTROL (COMPONENT); WIRE | Power Medical Interventions, Inc. | 2002-04-10 | 68 | 1 |
| K012809 | SURGASSIST RIGHT ANGLE LINEAR CUTTER DLU - 45MM, MODEL RALC4 | Power Medical Interventions, Inc. | 2001-10-26 | 65 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda