510(k) · Cleared
ClearedAcmi Rigi-Flex Nephorscope
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
American Cystocope Makers, Inc. · FGA Kit, Nephroscope
Cleared on Jul 30, 1979 after a 35-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 24 later devices descend from it.
- Decided
- Jul 30, 1979
- Review
- 35 days
- Class
- Class II
- Product code
- FGA
- Recalls
- None
- Predicates
- 0
24 later devices descend from it, 1 citing it directly.
- This deviceK791182 Acmi Rigi-Flex NephorscopeAmerican Cystocope Makers, Inc. · 1979
- Descendant · cites it directly · 23 of its ownK072594 Gyrus Acmi Ipn-2505, Invisio Smith Percutaneous Nephroscope SystemGyrus Acmi, Inc. · 2007
- Descendant · 2 generations on · 22 of its ownK092278 Gyrus Acmi Invisio Digital Hysteroscope, Model Idh-4Gyrus Acmi, Inc. · 2009
- Descendant · 3 generations on · 20 of its ownK123151 Endosee Model 8000 U-ScopeEndosee Corp · 2013
- Descendant · 4 generations on · 19 of its ownK132384 U-Scope 8000 System with HSC+Emb CannulaEndosec Corporation · 2014
- Descendant · 4 generations on · 5 of its ownK170660 Endosee Hysteroscope with Disposable Diagnostic (Dx) CannulaCooperSurgical, Inc. · 2017
Showing 5 of 24 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 24 · See all- K072594Gyrus Acmi Ipn-2505, Invisio Smith Percutaneous Nephroscope SystemGyrus Acmi, Inc. · 2007 · cites it directly23descendants
- K092278Gyrus Acmi Invisio Digital Hysteroscope, Model Idh-4Gyrus Acmi, Inc. · 2009 · 2 generations on22descendants
- K123151Endosee Model 8000 U-ScopeEndosee Corp · 2013 · 3 generations on20descendants
- K132384U-Scope 8000 System with HSC+Emb CannulaEndosec Corporation · 2014 · 4 generations on19descendants
- K170660Endosee Hysteroscope with Disposable Diagnostic (Dx) CannulaCooperSurgical, Inc. · 2017 · 4 generations on5descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K791182 | Acmi Rigi-Flex Nephorscope | American Cystocope Makers, Inc. | 1979 | — |
| +1 | K072594 | Gyrus Acmi Ipn-2505, Invisio Smith Percutaneous Nephroscope System | Gyrus Acmi, Inc. | 2007 | — |
| +2 | K092278 | Gyrus Acmi Invisio Digital Hysteroscope, Model Idh-4 | Gyrus Acmi, Inc. | 2009 | — |
| +3 | K123151 | Endosee Model 8000 U-Scope | Endosee Corp | 2013 | — |
| +4 | K132384 | U-Scope 8000 System with HSC+Emb Cannula | Endosec Corporation | 2014 | — |
| +4 | K170660 | Endosee Hysteroscope with Disposable Diagnostic (Dx) Cannula | CooperSurgical, Inc. | 2017 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 5 | 0 |
| 2020 | 2 | 0 |
| 2021 | 2 | 0 |
| 2024 | 3 | 0 |
| 2025 | 1 | 0 |
| 2026 | 2 | 0 |
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in FGA? 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 FGA device
- #1 K232370 Percutaneous Nephroscope Systemscore 5.3 · 1 generation · no Class I recall
What was it cleared against?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (24)
See all 241 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K072594 | Gyrus Acmi Ipn-2505, Invisio Smith Percutaneous Nephroscope System | 2007 | 23 |
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?
- Of its descendants, K072594 (Gyrus Acmi, Inc., 2007) has gone furthest, with 23 descendants of its own.
How does its category compare?
All FGA devicesFGA Kit, Nephroscope: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · FGA
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · FGA
Too few FGA 510(k)s in any year since 2007 to give a median.
Recalls per year · FGA
No recall names FGA since 2007.
Adverse event reports per year · FGA
36in 2025
MAUDE reports naming product code FGA, 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 | 1 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 2 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 1 |
| 2016 | 1 | — | 0 | 2 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 1 |
| 2019 | 0 | — | 0 | 1 |
| 2020 | 0 | — | 0 | 6 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 1 |
| 2023 | 0 | — | 0 | 11 |
| 2024 | 1 | — | 0 | 23 |
| 2025 | 0 | — | 0 | 36 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/K791182 · printed Nov 6, 2026
Cite this page
510(k) Report. “K791182: Acmi Rigi-Flex Nephorscope.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K791182
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026