510(k) · Cleared
ClearedMicroendoscope (8755.401,411,461,451)/External Sheath (8755.221,222)/Veress Cannula (8755.211,212)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Richard Wolf Medical Instruments Corp. · HIH Hysteroscope (And Accessories)
Cleared on Oct 22, 1997 as substantially equivalent to K962799 (Richard Wolf GmbH, 1996) after a 188-day review. Its family tree reaches back 1 generation to 1996. 2 later devices descend from it.
- Decided
- Oct 22, 1997
- Review
- 188 days
- Class
- Class II
- Product code
- HIH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K962799 (1996). 2 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK962799 Miniature Laparoscope Set (Mini Lap)Richard Wolf GmbH · 1996
- This deviceK971420 Microendoscope (8755.401,411,461,451)/External Sheath…Richard Wolf Medical Instruments Corp. · 1997
- Descendant · cites it directly · 1 of its ownK041321 Veroscope Optical Veress Cannula & Dilation Tube SystemRichard Wolf Medical Instruments Corp. · 2004
- Descendant · 2 generations on · 0 of its ownK062097 Veress Cannula and Modular Veress CannulaPAJUNK GmbH Medizintechnologie · 2006
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K962799 | Miniature Laparoscope Set (Mini Lap) | Richard Wolf GmbH | 1996 | — |
| 0 (this device) | K971420 | Microendoscope (8755.401,411,461,451)/External Sheath (8755.221,222)/Veress… | Richard Wolf Medical Instruments Corp. | 1997 | — |
| +1 | K041321 | Veroscope Optical Veress Cannula & Dilation Tube System | Richard Wolf Medical Instruments Corp. | 2004 | — |
| +2 | K062097 | Veress Cannula and Modular Veress Cannula | PAJUNK GmbH Medizintechnologie | 2006 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2006 | 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 HIH? 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 HIH device
- #1 K232003 Endoscopic Video Image Processor, Single-Use…score 16.1 · 12 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 |
|---|---|---|---|
| * | K962799 | Miniature Laparoscope Set (Mini Lap)Summary page 1…title: Quality Assurance Manager "Tfidfi name: Model number: Mini Laparoscopes 87550 || Common name: Classification name: i Set Laparoscopy 510(k) Manufacturer Number 1 K962799 1 Mini Laparoscopes 1 Richard Wolf M.I.C. 2 2 Surgy Needle VN-1500 2 IMAGYN 3 3 Veress Needle AN3SMM 3 Ethicon 4 4 OMS-PNS Pix… | 1996 |
| * | — | Surgy Needle VN-1500 Named without a submission number | |
| * | — | Veress Needle AN3SMM Named without a submission number | |
| * | — | OMS-PNS Pixie Microendoscope Named without a submission number |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K041321 | Veroscope Optical Veress Cannula & Dilation Tube System | 2004 | 1 |
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?
How does its category compare?
All HIH devicesHIH Hysteroscope (And Accessories): FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · HIH
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · HIH
111in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HIH
3so far in 2026, the most since 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HIH
1,698in 2025
MAUDE reports naming product code HIH, 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 | 7 |
| 2008 | 2 | — | 0 | 12 |
| 2009 | 4 | 130 | 0 | 17 |
| 2010 | 4 | 109 | 0 | 31 |
| 2011 | 3 | 118 | 0 | 59 |
| 2012 | 4 | 25 | 0 | 78 |
| 2013 | 5 | 144 | 0 | 111 |
| 2014 | 2 | — | 0 | 125 |
| 2015 | 5 | 52 | 0 | 211 |
| 2016 | 3 | 106 | 0 | 172 |
| 2017 | 2 | — | 0 | 336 |
| 2018 | 8 | 135 | 0 | 182 |
| 2019 | 14 | 91 | 1 | 220 |
| 2020 | 7 | 88 | 0 | 253 |
| 2021 | 4 | 194 | 0 | 193 |
| 2022 | 2 | — | 0 | 289 |
| 2023 | 4 | 200 | 2 | 1,449 |
| 2024 | 6 | 148 | 0 | 1,611 |
| 2025 | 3 | 111 | 0 | 1,698 |
| 2026 | 7 | 168 | 3 | — |
What is it indicated for?
The Microendoscope system is used to apply and maintain pneumoperitoneum for laparoscopic procedures
and to provide access and visualization for diagnostic and therapeutic purposes for laparoscopic and
hysteroscopic 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/K971420 · printed Nov 5, 2026
Cite this page
510(k) Report. “K971420: Microendoscope (8755.401,411,461,451)/External Sheath (8755.221,222)/Veress Cannula (8755.211,212).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K971420
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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