510(k) · Cleared
ClearedGelpoint Path Transanal Access Platform
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Applied Medical Resources Corp. · FER Anoscope And Accessories
Cleared on Jan 2, 2014 as substantially equivalent to K070915 (Sapimed S.P.A., 2007) and 1 other predicate after a 58-day review. Its family tree reaches back 8 generations to 1994. 1 later device descends from it.
- Decided
- Jan 2, 2014
- Review
- 58 days
- Class
- Class II
- Product code
- FER
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 8 generations to K940232 (1994). 30 ancestors in all, the oldest K770291 (1977). 1 later device descends from it, 1 citing it directly.
- Root · 8 generations backK940232 Innerdyne Step Trocar Expandable Port, S.T.E.P.Innerdyne Medical, Inc. · 1994
- 7 generations backK961940 Innerdyne Step Trocar Expandable Port, OnestepInnerdyne, Inc. · 1996 · Recalled
- 6 generations backK012539 VerastepUnited States Surgical, A Division of Tyco Healthc · 2001
- 5 generations backK072814 Convenience Kit for Single-Incision Laparoscopic Surgery and Other…Covidien · 2008
- 4 generations backK082619 Sils Port, Models SILSPT5, SILSPT12Covidien Lp, Formerly Registered AS United States · 2008
- 3 generations backK093372 Sils Port Model SILSPT15Covidien Lp, Formerly Registered AS Tyco Healthcar · 2009
- 2 generations backK103253 Sils PortCoviden (Formerly Registered AS US Surgical, A Div · 2011
- 1 generation backK110792 Gelpoint PathApplied Medical Resources Corp. · 2011
- This deviceK133393 Gelpoint Path Transanal Access PlatformApplied Medical Resources Corp. · 2014
- Descendant · cites it directly · 0 of its ownK171701 GelPOINT Path Transanal Access PlatformApplied Medical Resources Corp. · 2017 · Recalled
Most influential descendants
Showing 1 of 1 · See all- K171701GelPOINT Path Transanal Access PlatformApplied Medical Resources Corp. · 2017 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K940232 | Innerdyne Step Trocar Expandable Port, S.T.E.P. | Innerdyne Medical, Inc. | 1994 | — |
| −7 | K961940 | Innerdyne Step Trocar Expandable Port, Onestep | Innerdyne, Inc. | 1996 | 1 |
| −6 | K012539 | Verastep | United States Surgical, A Division of Tyco Healthc | 2001 | — |
| −5 | K072814 | Convenience Kit for Single-Incision Laparoscopic Surgery and Other Advanced… | Covidien | 2008 | — |
| −4 | K082619 | Sils Port, Models SILSPT5, SILSPT12 | Covidien Lp, Formerly Registered AS United States | 2008 | — |
| −3 | K093372 | Sils Port Model SILSPT15 | Covidien Lp, Formerly Registered AS Tyco Healthcar | 2009 | — |
| −2 | K103253 | Sils Port | Coviden (Formerly Registered AS US Surgical, A Div | 2011 | — |
| −1 | K110792 | Gelpoint Path | Applied Medical Resources Corp. | 2011 | — |
| 0 (this device) | K133393 | Gelpoint Path Transanal Access Platform | Applied Medical Resources Corp. | 2014 | — |
| +1 | K171701 | GelPOINT Path Transanal Access Platform | Applied Medical Resources Corp. | 2017 | 1 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1977 | 1 | 0 |
| 1988 | 1 | 0 |
| 1991 | 1 | 0 |
| 1992 | 2 | 0 |
| 1993 | 1 | 0 |
| 1994 | 3 | 0 |
| 1995 | 4 | 0 |
| 1998 | 1 | 0 |
| 2001 | 3 | 0 |
| 2003 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 3 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 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 FER? 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 FER device
- #1 K250645 SleeveLUX 24 Anoscope/Proctoscope (P2001)…score 10.7 · 3 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
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 |
|---|---|---|---|
| * | K070915 | Sapimed Disposable SigmoidoscopeSummary page 1…oenterology and Urology Devices, 21 CFR 876.1500. Product code PER, Anoscope and accessories. PREDICATE DEVICE: K070915, SAPIMED S.P.A. Disposable Sigmoidoscope! proctoscope; product code KOG. Endloscope and accessor… | 2007 |
| * | K110792 | Gelpoint PathSummary page 1…a simple, two-piece proctoscope but with signif[leant additional versatility, capability and effectiveness. INTENDED) USE: Trhe subject device was previously cleared in K 110792 and its intended use is unchanged. It provides access to the rectal cavity to perform surgery, which is also the intended use of… | 2011 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K171701 | GelPOINT Path Transanal Access Platform | 2017 | 0 |
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 20 years and passes through 8 companies; a new generation was cleared every 2.2 years on median.
- 5 of the 30 ancestors have a recall of any class.
- Of its descendants, K171701 (Applied Medical Resources Corp., 2017) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K070915.
How does its category compare?
All FER devicesFER Anoscope And Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.
FDA decisions per year · FER
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FER
Too few FER 510(k)s in any year since 2007 to give a median.
Recalls per year · FER
1in 2018
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · FER
3in 2025
MAUDE reports naming product code FER, 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 | 1 | — | 0 | 1 |
| 2009 | 2 | — | 0 | 0 |
| 2010 | 1 | — | 0 | 0 |
| 2011 | 2 | — | 0 | 0 |
| 2012 | 2 | — | 0 | 1 |
| 2013 | 1 | — | 0 | 1 |
| 2014 | 1 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 2 |
| 2016 | 0 | — | 0 | 14 |
| 2017 | 1 | — | 0 | 4 |
| 2018 | 0 | — | 1 | 4 |
| 2019 | 0 | — | 0 | 15 |
| 2020 | 0 | — | 0 | 18 |
| 2021 | 1 | — | 0 | 3 |
| 2022 | 0 | — | 0 | 3 |
| 2023 | 1 | — | 0 | 6 |
| 2024 | 1 | — | 0 | 0 |
| 2025 | 1 | — | 0 | 3 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The GeIPOINT Path Transanal Access Platform is indicated for
multiple instrument or camera access through the anus to perform various diagnostic and
therapeutic procedures by using additional accessories.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K133393 · printed Nov 5, 2026
Cite this page
510(k) Report. “K133393: Gelpoint Path Transanal Access Platform.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K133393
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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