510(k) · Cleared
ClearedGelpoint Path
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 May 23, 2011 as substantially equivalent to K103253 (Coviden (Formerly Registered AS US Surgical, A Div, 2011) after a 63-day review. Its family tree reaches back 7 generations to 1994. 3 later devices descend from it.
- Decided
- May 23, 2011
- Review
- 63 days
- Class
- Class II
- Product code
- FER
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to K940232 (1994). 27 ancestors in all, the oldest K883018 (1988). 3 later devices descend from it, 3 citing it directly.
- Root · 7 generations backK940232 Innerdyne Step Trocar Expandable Port, S.T.E.P.Innerdyne Medical, Inc. · 1994
- 6 generations backK961940 Innerdyne Step Trocar Expandable Port, OnestepInnerdyne, Inc. · 1996 · Recalled
- 5 generations backK012539 VerastepUnited States Surgical, A Division of Tyco Healthc · 2001
- 4 generations backK072814 Convenience Kit for Single-Incision Laparoscopic Surgery and Other…Covidien · 2008
- 3 generations backK082619 Sils Port, Models SILSPT5, SILSPT12Covidien Lp, Formerly Registered AS United States · 2008
- 2 generations backK093372 Sils Port Model SILSPT15Covidien Lp, Formerly Registered AS Tyco Healthcar · 2009
- 1 generation backK103253 Sils PortCoviden (Formerly Registered AS US Surgical, A Div · 2011
- This deviceK110792 Gelpoint PathApplied Medical Resources Corp. · 2011
- Descendant · cites it directly · 1 of its ownK133393 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
- Descendant · cites it directly · 0 of its ownK120898 Keyport System, Includes: Keyport Silicone Sealing Insert 8850XXX…Richard Wolf Medical Instruments Corp. · 2012
Most influential descendants
Showing 3 of 3 · See all- K133393Gelpoint Path Transanal Access PlatformApplied Medical Resources Corp. · 2014 · cites it directly1descendant
- K171701GelPOINT Path Transanal Access PlatformApplied Medical Resources Corp. · 2017 · cites it directly0descendants
- K120898Keyport System, Includes: Keyport Silicone Sealing Insert 8850XXX Keyport Trucar 8850XX…Richard Wolf Medical Instruments Corp. · 2012 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K940232 | Innerdyne Step Trocar Expandable Port, S.T.E.P. | Innerdyne Medical, Inc. | 1994 | — |
| −6 | K961940 | Innerdyne Step Trocar Expandable Port, Onestep | Innerdyne, Inc. | 1996 | 1 |
| −5 | K012539 | Verastep | United States Surgical, A Division of Tyco Healthc | 2001 | — |
| −4 | K072814 | Convenience Kit for Single-Incision Laparoscopic Surgery and Other Advanced… | Covidien | 2008 | — |
| −3 | K082619 | Sils Port, Models SILSPT5, SILSPT12 | Covidien Lp, Formerly Registered AS United States | 2008 | — |
| −2 | K093372 | Sils Port Model SILSPT15 | Covidien Lp, Formerly Registered AS Tyco Healthcar | 2009 | — |
| −1 | K103253 | Sils Port | Coviden (Formerly Registered AS US Surgical, A Div | 2011 | — |
| 0 (this device) | K110792 | Gelpoint Path | Applied Medical Resources Corp. | 2011 | — |
| +1 | K133393 | Gelpoint Path Transanal Access Platform | Applied Medical Resources Corp. | 2014 | — |
| +1 | K171701 | GelPOINT Path Transanal Access Platform | Applied Medical Resources Corp. | 2017 | 1 |
| +1 | K120898 | Keyport System, Includes: Keyport Silicone Sealing Insert 8850XXX Keyport… | Richard Wolf Medical Instruments Corp. | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2014 | 1 | 0 |
| 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? (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 |
|---|---|---|---|
| * | K103253 | Sils PortSummary page 1…Accessories, Gastroenterology and Urology Devices, 21CFR 876. 1500, product code PER. PREDICATE DEVICE: Covidien SILSTM Port. K103253 DEVICE DESCRIPTION: The GeIPOINT Path is a sterile, single use, disposable surgical instrument designed to p… | 2011 |
What descends from it? (3)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 17 years and passes through 8 companies; a new generation was cleared every 1.2 years on median.
- 4 of the 27 ancestors have a recall of any class.
- Of its descendants, K133393 (Applied Medical Resources Corp., 2014) has gone furthest, with 1 descendant of its own.
- 1 other device also cites its predicate K103253.
How does its category compare?
All FER devicesFER Anoscope And Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, 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 is indicated for multiple instrument or camera access through the anus for rectal procedures such as TEMS (Transanal Endoscopic Micro Surgery), flap revision, and fistula repair.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K110792 · printed Nov 6, 2026
Cite this page
510(k) Report. “K110792: Gelpoint Path.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K110792
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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