510(k) · Cleared
ClearedNovacyte Microendoscope and Accessories, Models NC1000;NCAM1000
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cytyc Surgical Products · GCJ Laparoscope, General & Plastic Surgery
Cleared on May 16, 2005 as substantially equivalent to K011189 (Acueity, Inc., 2001) and 1 other predicate after a 63-day review. Its family tree reaches back 2 generations to 1994.
- Decided
- May 16, 2005
- Review
- 63 days
- Class
- Class II
- Product code
- GCJ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K932987 (1994). 3 ancestors in all. No later device cites it as a predicate yet.
- Root · 2 generations backK932987 Birtcher Laparoscope and AccessoriesBirtcher Medical Systems, Inc. · 1994
- 1 generation backK020310 Davlite Microendoscope & AccessoriesDavlite Technologies · 2002
- This deviceK050650 Novacyte Microendoscope and Accessories, Models NC1000;NCAM1000Cytyc Surgical Products · 2005
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K932987 | Birtcher Laparoscope and Accessories | Birtcher Medical Systems, Inc. | 1994 | — |
| −1 | K020310 | Davlite Microendoscope & Accessories | Davlite Technologies | 2002 | — |
| 0 (this device) | K050650 | Novacyte Microendoscope and Accessories, Models NC1000;NCAM1000 | Cytyc Surgical Products | 2005 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 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 GCJ? 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 GCJ device
- #1 K214046 780 nm 1688 4K Camera System, 780 nm L11 LED…score 21.4 · 21 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 |
|---|---|---|---|
| * | K011189 | Viaduct Microendoscope and Accessories Our reading of the summary gave K001189, FDA’s number for Modification to Convertors Surgical Gowns (Allegiance Healthcare Corp.). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Acueity Microendoscope (Viaduct)”. | 2001 |
| * | K020310 | Davlite Microendoscope & AccessoriesSummary page 1…ysical characteristics and geometry between the Cytyc Surgical NovaCyte Microendoscope and the Acueity Microendoscope (Viaduct) (KO01189) and the Davlite Microendoscope (K020310) among other marketed visualization products. Cytyc Surgical Products, 1047 Elwell Ct. Palo Alto, CA 94303… | 2002 |
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 11 years and passes through 3 companies; a new generation was cleared every 7.9 years on median.
- None of the 3 ancestors has a recall.
- 5 other devices also cite its predicate K011189.
How does its category compare?
All GCJ devicesGCJ Laparoscope, General & Plastic Surgery: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · GCJ
21in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · GCJ
108in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GCJ
5in 2025
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · GCJ
5,860in 2025
MAUDE reports naming product code GCJ, 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 | 18 | 42 | 12 | 1,639 |
| 2008 | 19 | 73 | 16 | 1,319 |
| 2009 | 21 | 85 | 6 | 1,995 |
| 2010 | 24 | 122 | 30 | 2,657 |
| 2011 | 15 | 113 | 9 | 2,133 |
| 2012 | 17 | 88 | 1 | 1,526 |
| 2013 | 15 | 93 | 7 (1) | 1,565 |
| 2014 | 19 | 90 | 2 | 1,714 |
| 2015 | 26 | 76 | 0 | 1,710 |
| 2016 | 27 | 99 | 5 | 2,080 |
| 2017 | 20 | 77 | 1 | 3,468 |
| 2018 | 21 | 88 | 1 | 2,562 |
| 2019 | 15 | 60 | 0 | 2,578 |
| 2020 | 28 | 61 | 0 | 2,618 |
| 2021 | 18 | 116 | 0 | 3,431 |
| 2022 | 20 | 103 | 1 | 3,945 |
| 2023 | 31 | 109 | 1 | 6,002 |
| 2024 | 29 | 90 | 0 | 6,047 |
| 2025 | 21 | 108 | 5 | 5,860 |
| 2026 | 26 | 122 | 1 | — |
What is it indicated for?
This device is to be used by a physician for viewing an interior cavity of the human body through either a natural opening or incision.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K050650 · printed Nov 6, 2026
Cite this page
510(k) Report. “K050650: Novacyte Microendoscope and Accessories, Models NC1000;NCAM1000.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K050650
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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