510(k) · Cleared
ClearedRigid Fiber Optic Laparoscope
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Health Care International Assoc. · HET Laparoscope, Gynecologic (And Accessories)
Cleared on Feb 7, 1997 as substantially equivalent to K944079 (Imagyn Medical, Inc., 1995) and 3 other predicates after a 241-day review. Its family tree reaches back 1 generation to 1992.
- Decided
- Feb 7, 1997
- Review
- 241 days
- Class
- Class II
- Product code
- HET
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 1 generation to K921883 (1992). 4 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK921883 EndoscopeOptimed Technologies, Inc. · 1992
- This deviceK962246 Rigid Fiber Optic LaparoscopeHealth Care International Assoc. · 1997
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K921883 | Endoscope | Optimed Technologies, Inc. | 1992 | — |
| 0 (this device) | K962246 | Rigid Fiber Optic Laparoscope | Health Care International Assoc. | 1997 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 1995 | 2 | 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 HET? 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 HET device
- #1 K250939 SIRIUS Endoscope System (PR-SI-1230)score 12.9 · 11 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (4)
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 |
|---|---|---|---|
| * | K944079 | Imagyn Microlap (TM) LaparoscopeSummary page 1…are substantially equivalent to the following predicate devices: e Imagyn Medical, Inc. MicroLap™ Laparoscope Approved by FDA for marketing on 20-Jan-95 under 510(k) # K944079. e Olympus America, Inc. Mini Laparoscope for General Surgery Approved by FDA for marketing on 01-Feb-95 under 510(k) #K950278.… | 1995 |
| * | K950278 | Mini Laparoscopy for General SurgerySummary page 1…for marketing on 20-Jan-95 under 510(k) # K944079. e Olympus America, Inc. Mini Laparoscope for General Surgery Approved by FDA for marketing on 01-Feb-95 under 510(k) #K950278. e Optimed Technologies, Inc. OptiMIS® Series 300 Rigid Fiber Optic Laparoscopes Approved by FDA for marketing on 23-Nov-92 unde… | 1995 |
| * | K921883 | EndoscopeSummary page 1…1-Feb-95 under 510(k) #K950278. e Optimed Technologies, Inc. OptiMIS® Series 300 Rigid Fiber Optic Laparoscopes Approved by FDA for marketing on 23-Nov-92 under 510(k) #K921883 for abdominal laparoscopy and other indicated uses, and on 12-Jul-94 under 510(k) #K926597 for gynecologic laparoscopy. Descript… | 1992 |
| * | K926597 | Laparoscope, Gynecologic (and Accessories)Summary page 1…er Optic Laparoscopes Approved by FDA for marketing on 23-Nov-92 under 510(k) #K921883 for abdominal laparoscopy and other indicated uses, and on 12-Jul-94 under 510(k) #K926597 for gynecologic laparoscopy. Description of Device: Saber Endoscopy’s Rigid Fiber Optic Laparoscopes are small diameter endosco… | 1994 |
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?
- None of the 4 ancestors has a recall.
- 1 other device also cites its predicate K944079.
How does its category compare?
All HET devicesHET Laparoscope, Gynecologic (And Accessories): FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · HET
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · HET
269in 2021
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HET
4in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HET
4,513in 2025
MAUDE reports naming product code HET, 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 | 0 | — | 0 | 181 |
| 2008 | 3 | 176 | 4 | 359 |
| 2009 | 1 | — | 1 | 403 |
| 2010 | 1 | — | 0 | 214 |
| 2011 | 2 | — | 0 | 417 |
| 2012 | 2 | — | 0 | 1,118 |
| 2013 | 2 | — | 0 | 1,035 |
| 2014 | 0 | — | 0 | 175 |
| 2015 | 2 | — | 1 | 124 |
| 2016 | 0 | — | 0 | 205 |
| 2017 | 2 | — | 0 | 89 |
| 2018 | 1 | — | 0 | 53 |
| 2019 | 2 | — | 0 | 44 |
| 2020 | 2 | — | 0 | 49 |
| 2021 | 4 | 269 | 0 | 132 |
| 2022 | 1 | — | 1 | 216 |
| 2023 | 0 | — | 4 | 824 |
| 2024 | 0 | — | 0 | 3,496 |
| 2025 | 2 | — | 0 | 4,513 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
Saber’s Rigid Fiber Optic Laparoscopes are used to permit direct viewing of the organs within the peritoneal cavity for the purpose of performing diagnostic and surgical procedures.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K962246 · printed Nov 4, 2026
Cite this page
510(k) Report. “K962246: Rigid Fiber Optic Laparoscope.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K962246
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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