Computer Motion, Inc.: FDA filings under this applicant name
FDA lists 26 510(k) clearances under the applicant name “Computer Motion, Inc.” (first 1993, latest 2003), across 4 product codes in 1 review panel. Median 510(k) review time under this name: 60 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 Intuitive Surgical, 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 |
|---|---|---|---|
| GCJ | Laparoscope, General & Plastic Surgery | 21 | 21 |
| NAY | System, Surgical, Computer Controlled Instrument | 2 | 2 |
| NEQ | Device, Telemedicine, Robotic | 2 | 2 |
| GCI | Laryngoscope, Endoscope | 1 | 1 |
Review panels
Most recent Computer Motion, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K031956 | MODIFICATION TO HERMES O.R. CONTROL CENTER | GCJ | 2003-07-17 | 22 |
| K031720 | MODIFICATION TO HERMES O.R. CONTROL CENTER | GCJ | 2003-07-11 | 38 |
| K031382 | MODIFICATION TO HERMES O.R. CONTROL CENTER | GCJ | 2003-06-30 | 60 |
| K030578 | BIPOLAR GRASPER AND BIPOLAR SCISSORS FOR THE ZEUS MICROWRIST SURGICAL SYSTEM | NAY | 2003-06-24 | 120 |
| K030718 | SCB COMPUTER MOTION INTERFACE CONTROLLER | GCJ | 2003-06-05 | 90 |
| K030240 | MODIFICATION TO HERMES OPERATING ROOM CONTROL CENTER | GCJ | 2003-02-21 | 29 |
| K024294 | MODIFICATION TO HERMES OPERATING ROOM CONTROL CENTER | GCJ | 2003-01-08 | 15 |
| K023095 | HERMES OPERATING ROOM CONTROL CENTER | GCJ | 2002-11-15 | 58 |
| K022897 | MODIFICATION TO HERMES OPERATING ROOM CONTROL CENTER | GCJ | 2002-10-11 | 38 |
| K021152 | ZEUS MICROWRIST ROBOTIC SURGICAL SYSTEM AND ACCESSORIES | NAY | 2002-09-24 | 167 |
16 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Computer Motion, 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.
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.
- Computer Dialysis Systems, Inc. (4 510(k)s)
- Computer Design & Applications, Inc. (3 510(k)s)
- Computer Programs and Systems, Inc. (1 510(k)s)
- Computer Sports Medicine, Inc. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Computer Motion, Inc.?
FDA lists 26 510(k) clearances under the applicant name “Computer Motion, Inc.” (first 1993, latest 2003), across 4 product codes 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 Computer Motion, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Computer Motion, Inc. is 60 days.
Which FDA product codes appear under Computer Motion, Inc.?
The most frequent FDA product codes under this applicant name are GCJ (Laparoscope, General & Plastic Surgery, 21); NAY (System, Surgical, Computer Controlled Instrument, 2); NEQ (Device, Telemedicine, Robotic, 2).
Next steps
- See all 26 Computer Motion, Inc. clearances with predicates and recalls
- Run predicate analysis for product code GCJ, Computer Motion, 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.