510(k) · Cleared
Recalled · Class II · 2018GelPOINT 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 Jul 20, 2017 as substantially equivalent to K133393 (Applied Medical Resources Corp., 2014) and 1 other predicate after a 42-day review. Its family tree reaches back 9 generations to 1994. It has been recalled once.
- Decided
- Jul 20, 2017
- Review
- 42 days
- Class
- Class II
- Product code
- FER
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 9 generations to K940232 (1994). 31 ancestors in all, the oldest K770291 (1977). No later device cites it as a predicate yet.
- Root · 9 generations backK940232 Innerdyne Step Trocar Expandable Port, S.T.E.P.Innerdyne Medical, Inc. · 1994
- 5 generations between
- 3 generations backK103253 Sils PortCoviden (Formerly Registered AS US Surgical, A Div · 2011
- 2 generations backK110792 Gelpoint PathApplied Medical Resources Corp. · 2011
- 1 generation backK133393 Gelpoint Path Transanal Access PlatformApplied Medical Resources Corp. · 2014
- This deviceK171701 GelPOINT Path Transanal Access PlatformApplied Medical Resources Corp. · 2017
Show all 9 generations
- Root · 9 generations backK940232 Innerdyne Step Trocar Expandable Port, S.T.E.P.Innerdyne Medical, Inc. · 1994
- 8 generations backK961940 Innerdyne Step Trocar Expandable Port, OnestepInnerdyne, Inc. · 1996 · Recalled
- 7 generations backK012539 VerastepUnited States Surgical, A Division of Tyco Healthc · 2001
- 6 generations backK072814 Convenience Kit for Single-Incision Laparoscopic Surgery and Other…Covidien · 2008
- 5 generations backK082619 Sils Port, Models SILSPT5, SILSPT12Covidien Lp, Formerly Registered AS United States · 2008
- 4 generations backK093372 Sils Port Model SILSPT15Covidien Lp, Formerly Registered AS Tyco Healthcar · 2009
- 3 generations backK103253 Sils PortCoviden (Formerly Registered AS US Surgical, A Div · 2011
- 2 generations backK110792 Gelpoint PathApplied Medical Resources Corp. · 2011
- 1 generation backK133393 Gelpoint Path Transanal Access PlatformApplied Medical Resources Corp. · 2014
- This deviceK171701 GelPOINT Path Transanal Access PlatformApplied Medical Resources Corp. · 2017
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K940232 | Innerdyne Step Trocar Expandable Port, S.T.E.P. | Innerdyne Medical, Inc. | 1994 | — |
| −8 | K961940 | Innerdyne Step Trocar Expandable Port, Onestep | Innerdyne, Inc. | 1996 | 1 |
| −7 | K012539 | Verastep | United States Surgical, A Division of Tyco Healthc | 2001 | — |
| −6 | K072814 | Convenience Kit for Single-Incision Laparoscopic Surgery and Other Advanced… | Covidien | 2008 | — |
| −5 | K082619 | Sils Port, Models SILSPT5, SILSPT12 | Covidien Lp, Formerly Registered AS United States | 2008 | — |
| −4 | K093372 | Sils Port Model SILSPT15 | Covidien Lp, Formerly Registered AS Tyco Healthcar | 2009 | — |
| −3 | K103253 | Sils Port | Coviden (Formerly Registered AS US Surgical, A Div | 2011 | — |
| −2 | K110792 | Gelpoint Path | Applied Medical Resources Corp. | 2011 | — |
| −1 | K133393 | Gelpoint Path Transanal Access Platform | Applied Medical Resources Corp. | 2014 | — |
| 0 (this device) | K171701 | GelPOINT Path Transanal Access Platform | Applied Medical Resources Corp. | 2017 | — |
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 |
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 |
|---|---|---|---|
| * | K133393 | Gelpoint Path Transanal Access PlatformSummary page 4…ass II Product Code: FER Predicate Device: Applied Medical’s GelPOINT® Path Transanal Access Platform 510(k)#: K133393 and K110792 Product Code: FER Device Description: GelPOINT Path is inserted into the anal canal t… | 2014 |
| * | K110792 | Gelpoint PathSummary page 4…Product Code: FER Predicate Device: Applied Medical’s GelPOINT® Path Transanal Access Platform 510(k)#: K133393 and K110792 Product Code: FER Device Description: GelPOINT Path is inserted into the anal canal to establish… | 2011 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Dec 12, 2018 | Class II | Z-0510-2020 | Device Design | Unintentional shifting of the tip insulation of the firm's electrosurgical probes. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 23 years and passes through 8 companies; a new generation was cleared every 2.2 years on median.
- 5 of the 31 ancestors have a recall of any class.
How does its category compare?
All FER devicesFER Anoscope And Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, 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 GelPOINT Path Transanal Access Platform is indicated for multiple instrument or camera access through the anus to perform various diagnostic and/or therapeutic procedures by using additional instruments.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K171701 · printed Nov 6, 2026
Cite this page
510(k) Report. “K171701: GelPOINT Path Transanal Access Platform.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K171701
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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