510(k) · Cleared
ClearedSurroundScope System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
270surgical, Ltd. · HET Laparoscope, Gynecologic (And Accessories)
Cleared on Jul 8, 2021 as substantially equivalent to K190190 (270surgical, Ltd., 2019) after a 175-day review. Its family tree reaches back 3 generations to 1996.
- Decided
- Jul 8, 2021
- Review
- 175 days
- Class
- Class II
- Product code
- HET
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K955456 (1996). 4 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK955456 Oes Laparo-Thoraco Videoscope (Rigid)Olympus America, Inc. · 1996
- 2 generations backK111788 Endoeye HD IIOlympus America, Inc. · 2012 · Recalled
- 1 generation backK190190 WV1 Endoscope270surgical, Ltd. · 2019
- This deviceK210104 SurroundScope System270surgical, Ltd. · 2021
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K955456 | Oes Laparo-Thoraco Videoscope (Rigid) | Olympus America, Inc. | 1996 | — |
| −2 | K111788 | Endoeye HD II | Olympus America, Inc. | 2012 | 2 |
| −1 | K190190 | WV1 Endoscope | 270surgical, Ltd. | 2019 | — |
| 0 (this device) | K210104 | SurroundScope System | 270surgical, Ltd. | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in HET? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new HET device
- #1 K250939 SIRIUS Endoscope System (PR-SI-1230)score 12.9 · 11 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K190190 | WV1 EndoscopeSummary page 4…scope, Gynecologic (And Accessories)) Additional Product Code: GCJ (Laparoscope, General & Plastic surgery) 3. Predicate and Reference Device Information Predicate: K190190, 270Surgical, WV1 Endoscope Reference: K151011, Olympus Medical Systems Corp., VISERA 4K UHD SYSTEM Endoscopic Imaging System. T… | 2019 |
| † | K151011 | Visera 4K Uhd System | 2015 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 25 years and passes through 2 companies; a new generation was cleared every 7.8 years on median.
- 1 of the 4 ancestors has a recall of any class.
How does its category compare?
All HET devicesHET Laparoscope, Gynecologic (And Accessories): FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, this device’s year, is highlighted.
FDA decisions per year · HET
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · HET
269in 2021
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HET
4in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HET
4,513in 2025
MAUDE reports naming product code HET, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 181 |
| 2008 | 3 | 176 | 4 | 359 |
| 2009 | 1 | — | 1 | 403 |
| 2010 | 1 | — | 0 | 214 |
| 2011 | 2 | — | 0 | 417 |
| 2012 | 2 | — | 0 | 1,118 |
| 2013 | 2 | — | 0 | 1,035 |
| 2014 | 0 | — | 0 | 175 |
| 2015 | 2 | — | 1 | 124 |
| 2016 | 0 | — | 0 | 205 |
| 2017 | 2 | — | 0 | 89 |
| 2018 | 1 | — | 0 | 53 |
| 2019 | 2 | — | 0 | 44 |
| 2020 | 2 | — | 0 | 49 |
| 2021 | 4 | 269 | 0 | 132 |
| 2022 | 1 | — | 1 | 216 |
| 2023 | 0 | — | 4 | 824 |
| 2024 | 0 | — | 0 | 3,496 |
| 2025 | 2 | — | 0 | 4,513 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The SurroundScope System is designed to be used with documentation equipment, monitor, hand instruments, electrosurgical unit, and other ancillary equipment for endoscopy and endoscopic surgery within the thoracic and abdominal cavities, including the female reproductive organs.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K210104 · printed Nov 6, 2026
Cite this page
510(k) Report. “K210104: SurroundScope System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K210104
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026