Given Imaging , Ltd.: FDA filings under this applicant name
FDA lists 28 510(k) clearances under the applicant name “Given Imaging , Ltd.” (first 2002, latest 2018), plus 2 De Novo decisions, across 5 product codes in 1 review panel. Median 510(k) review time under this name: 90 days. Since 2017 the median was 66 days, against 124 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.
Caduvo groups this applicant name under Medtronic, based on public ownership records.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 1 | 238 |
| 2014 | 1 | 316 |
| 2015 | 0 | — |
| 2016 | 2 | 208 |
| 2017 | 2 | 143 |
| 2018 | 1 | 45 |
| 2019 | 0 | — |
| 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 Given Imaging , Ltd. took a median 66 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 124 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| NEZ | System, Imaging, Gastrointestinal, Wireless, Capsule | 19 | 18 |
| NSI | System, Imaging, Esophageal, Wireless, Capsule | 7 | 7 |
| PGD | Colon Capsule Imaging System | 2 | 1 |
| FFT | Electrode, Ph, Stomach | 1 | 1 |
| FFX | System, Gastrointestinal Motility (Electrical) | 1 | 1 |
Review panels
Most recent Given Imaging , Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K180171 | PillCam Patency System | NSI | 2018-03-08 | 45 |
| K170210 | PillCam SBC capsule endoscopy system, PilCam Desktop Software 9.0 | NEZ | 2017-09-01 | 220 |
| K170839 | RAPID Web | NEZ | 2017-05-26 | 66 |
| K151086 | ManoScan System | FFX | 2016-04-28 | 372 |
| K153466 | PillCam COLON 2 Capsule Endoscopy System | PGD | 2016-01-14 | 44 |
| K140284 | GIVEN PILLCAM UGI CAPSULE ENDOSCOPY SYSTEM | NEZ | 2014-12-17 | 316 |
| K123864 | GIVEN PILLCAM ENDOSCOPY SYSTEM WITH RAPID 8.0, GIVEN PILLCAM SB 3 CAPSULE ENDOSCOPY SYSTEM | NEZ | 2013-08-12 | 238 |
| K103025 | GIVEN PILLCAM PLATFORM WITH RAPID 6.5 / GIVEN PILLCAM PLATFORM WITH PILLCAM ESO 3 CAPSULES | NEZ | 2011-05-13 | 213 |
| K101250 | GIVEN PILLCAM PLATFORM WITH PILLCAM SB CAPSULES | NEZ | 2011-03-07 | 307 |
| K103088 | GIVEN PILLCAM PLATFORM WITH PILLCAM SB CAPSULESWITH PILLCAM R SENSORBELT | NEZ | 2011-01-14 | 87 |
18 earlier clearances. See the full list in Caduvo.
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| DEN120023 | De Novo | Colon Capsule Imaging System | 2014-01-29 |
| DEN010002 | De Novo | System, Imaging, Gastrointestinal, Wireless, Capsule | 2001-08-01 |
Recalls
4 product recalls in 4 recall events; 2 initiated in the last five years. Most recent: 2026-08-06.
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.
- Given Imaging Ltd. (Medtronic) (2 510(k)s)
- Given Imaging Ltd. (D.B.A. Medtronic) (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Given Imaging , Ltd.?
FDA lists 28 510(k) clearances under the applicant name “Given Imaging , Ltd.” (first 2002, latest 2018), plus 2 De Novo decisions, across 5 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 Given Imaging , Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Given Imaging , Ltd. is 90 days. Since 2017: 66 days, versus 124 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Given Imaging , Ltd.?
The most frequent FDA product codes under this applicant name are NEZ (System, Imaging, Gastrointestinal, Wireless, Capsule, 19); NSI (System, Imaging, Esophageal, Wireless, Capsule, 7); PGD (Colon Capsule Imaging System, 2).
Next steps
- See all 28 Given Imaging , Ltd. clearances with predicates and recalls
- Run predicate analysis for product code NEZ, Given Imaging , Ltd.'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 (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.