510(k) · Cleared
ClearedEndoscopic Introducer
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Novadaq Technologies, Inc. · FED Endoscopic Access Overtube, Gastroenterology-Urology
Cleared on Mar 22, 2013 as substantially equivalent to K092221 (United States Endoscopy Group, Inc., 2009) and 2 other predicates after a 175-day review. Its family tree reaches back 4 generations to 1994.
- Decided
- Mar 22, 2013
- Review
- 175 days
- Class
- Class II
- Product code
- FED
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 4 generations to K942044 (1994). 16 ancestors in all, the oldest K770291 (1977). No later device cites it as a predicate yet.
- Root · 4 generations backK942044 Bard Endoscopic OvertubeC.R. Bard, Inc. · 1994
- 3 generations backK002018 Ndo Surgical Surgical OvertubeSurgical, Inc. · 2000
- 2 generations backK023902 Shape-Lockable Endoscopic OvertubeUsgi Medical, Inc. · 2003
- 1 generation backK033954 Shape Locking Endoscopic OvertubeUsgi Medical, Inc. · 2004
- This deviceK123013 Endoscopic IntroducerNovadaq Technologies, Inc. · 2013
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K942044 | Bard Endoscopic Overtube | C.R. Bard, Inc. | 1994 | — |
| −3 | K002018 | Ndo Surgical Surgical Overtube | Surgical, Inc. | 2000 | — |
| −2 | K023902 | Shape-Lockable Endoscopic Overtube | Usgi Medical, Inc. | 2003 | — |
| −1 | K033954 | Shape Locking Endoscopic Overtube | Usgi Medical, Inc. | 2004 | — |
| 0 (this device) | K123013 | Endoscopic Introducer | Novadaq Technologies, Inc. | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1977 | 1 | 0 |
| 1986 | 1 | 0 |
| 1991 | 1 | 0 |
| 1993 | 1 | 0 |
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 2000 | 1 | 0 |
| 2002 | 1 | 0 |
| 2004 | 2 | 0 |
| 2005 | 1 | 0 |
| 2009 | 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 FED? 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 FED device
- #1 K241181 Disposable Ureteral Guide Sheathscore 15.0 · 5 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (3)
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 |
|---|---|---|---|
| * | K092221 | Colonic Splinting Overtube, Model 00711145Summary page 1…opic Access Overtube Classification: 21 OFA § 876.1500 Product Code: 78 (FED) Classification: Class 11 Predicate Devices: K092221 Colonic Splinting Overtube (US Endoscopy) K033954 Shape Locking Endoscopi… | 2009 |
| * | K033954 | Shape Locking Endoscopic OvertubeSummary page 1…lassification: Class 11 Predicate Devices: K092221 Colonic Splinting Overtube (US Endoscopy) K033954 Shape Locking Endoscopic Overtube (USGI Medical Inc.) K770291 Disposable… | 2004 |
| * | K770291 | Sigmoidoscope, Disposable, Model #53125Summary page 1…(US Endoscopy) K033954 Shape Locking Endoscopic Overtube (USGI Medical Inc.) K770291 Disposable Rigid Sigmoidoscope (Welch Allyn) Device Description: The single-use Disposable Rigid Sco… | 1977 |
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 19 years and passes through 4 companies; a new generation was cleared every 6.2 years on median.
- 2 of the 16 ancestors have a recall of any class.
- 1 other device also cites its predicate K092221.
How does its category compare?
All FED devicesFED Endoscopic Access Overtube, Gastroenterology-Urology: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.
FDA decisions per year · FED
11in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FED
120in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FED
4in 2024
Class I (4 since 2007) Class II/III not classified
Adverse event reports per year · FED
115in 2025
MAUDE reports naming product code FED, 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 | — | 1 | 14 |
| 2008 | 1 | — | 0 | 18 |
| 2009 | 4 | 90 | 0 | 19 |
| 2010 | 3 | 90 | 0 | 19 |
| 2011 | 1 | — | 0 | 20 |
| 2012 | 4 | 82 | 0 | 35 |
| 2013 | 2 | — | 3 | 25 |
| 2014 | 4 | 123 | 0 | 34 |
| 2015 | 2 | — | 0 | 35 |
| 2016 | 5 | 126 | 0 | 29 |
| 2017 | 1 | — | 0 | 32 |
| 2018 | 4 | 122 | 0 | 34 |
| 2019 | 5 | 94 | 0 | 30 |
| 2020 | 4 | 117 | 0 | 33 |
| 2021 | 3 | 189 | 0 | 55 |
| 2022 | 1 | — | 0 | 36 |
| 2023 | 3 | 138 | 0 | 53 |
| 2024 | 6 | 98 | 4 (4) | 64 |
| 2025 | 11 | 120 | 0 | 115 |
| 2026 | 6 | 67 | 0 | — |
What is it indicated for?
The Novadaq Disposable Rigid Scope Introducer is intended to facilitate passage of a laparoscope through the anus allowing visual examination of the rectum and distal portions of the colon.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K123013 · printed Nov 6, 2026
Cite this page
510(k) Report. “K123013: Endoscopic Introducer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K123013
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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