510(k) Report

510(k) · Cleared

Cleared

Continuous Irrigation Resectoscope Syst/Gynecology

K895857510(k) TraditionalCleared Jun 22, 1990262-day reviewClass II21 CFR 884.1690

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Richard Wolf Medical Instruments Corp. · HIH Hysteroscope (And Accessories)

Cleared on Jun 22, 1990 after a 262-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 20 later devices descend from it.

Decided
Jun 22, 1990
Review
262 days
Class
Class II
Product code
HIH
Recalls
None
Predicates
0

20 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 1998: 1 descendant cleared2005: 1 descendant cleared2001: 1 descendant cleared2010: 1 descendant cleared2007: 1 descendant cleared2014: 2 descendants cleared2026: 1 descendant cleared2006: 1 descendant cleared2019: 2 descendants cleared2015: 1 descendant cleared2025: 2 descendants cleared2016: 1 descendant cleared2017: 1 descendant cleared2020: 2 descendants cleared2024: 1 descendant cleared2021: 1 descendant cleared1990200020102020
  1. This deviceK895857 Continuous Irrigation Resectoscope Syst/GynecologyRichard Wolf Medical Instruments Corp. · 1990
  2. Descendant · cites it directly · 19 of its ownK980302 Working Elements, Resectoscope Sheaths, Electrodes, Obturators…Richard Wolf Medical Instruments Corp. · 1998 · Recalled
  3. Descendant · 2 generations on · 12 of its ownK011496 Cysto-Urethroscopes E-Line Existing of: Sheaths, Obturators…Richard Wolf Medical Instruments Corp. · 2001
  4. Descendant · 3 generations on · 10 of its ownK132389 Cellvizio 100 Series System and Cellvizio System with Confocal…Daniel & Daniel Consulting · 2014
  5. Descendant · 4 generations on · 9 of its ownK141358 Cellvizio 100 Series with System Confocal MiniprobesMauna Kea Technologies · 2014
  6. Descendant · 5 generations on · 7 of its ownK160416 CystoFlex UHD R-C, CelioFlex UHD 5-C, Cellvizio 100 Series (800)…Mauna Kea Technologies · 2016

Showing 5 of 20 descendants. See all descendants

Descendants cleared per year

1998: 12001: 12005: 12006: 12007: 12010: 12014: 22015: 12016: 12017: 12019: 22020: 22021: 12024: 12025: 22026: 1
1998high 2 (2014) · low 0 (1999)2026

Most influential descendants

Showing 5 of 20 · See all
  • K980302Working Elements, Resectoscope Sheaths, Electrodes, Obturators, EndoscopesRichard Wolf Medical Instruments Corp. · 1998 · cites it directly19descendants
  • K011496Cysto-Urethroscopes E-Line Existing of: Sheaths, Obturators, Inserts, Attchements, and…Richard Wolf Medical Instruments Corp. · 2001 · 2 generations on12descendants
  • K132389Cellvizio 100 Series System and Cellvizio System with Confocal Miniprobes; Uroflex B and…Daniel & Daniel Consulting · 2014 · 3 generations on10descendants
  • K141358Cellvizio 100 Series with System Confocal MiniprobesMauna Kea Technologies · 2014 · 4 generations on9descendants
  • K160416CystoFlex UHD R-C, CelioFlex UHD 5-C, Cellvizio 100 Series (800) with Confocal MiniprobesMauna Kea Technologies · 2016 · 5 generations on7descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K895857Continuous Irrigation Resectoscope Syst/GynecologyRichard Wolf Medical Instruments Corp.1990—
+1K980302Working Elements, Resectoscope Sheaths, Electrodes, Obturators, EndoscopesRichard Wolf Medical Instruments Corp.19981
+2K011496Cysto-Urethroscopes E-Line Existing of: Sheaths, Obturators, Inserts…Richard Wolf Medical Instruments Corp.2001—
+3K132389Cellvizio 100 Series System and Cellvizio System with Confocal Miniprobes…Daniel & Daniel Consulting2014—
+4K141358Cellvizio 100 Series with System Confocal MiniprobesMauna Kea Technologies2014—
+5K160416CystoFlex UHD R-C, CelioFlex UHD 5-C, Cellvizio 100 Series (800) with Confocal…Mauna Kea Technologies2016—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199810
200110
200510
200610
200710
201010
201420
201510
201610
201710
201920
202020
202110
202410
202520
202610
FIG. 1 — Lineage of K895857, 1990–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), 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. #1 K232003 Endoscopic Video Image Processor, Single-Use…score 16.1 · 12 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (20)

See all 20

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K980302Working Elements, Resectoscope Sheaths, Electrodes, Obturators, EndoscopesRichard Wolf Medical Instruments Corp.199819

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?

  • Of its descendants, K980302 (Richard Wolf Medical Instruments Corp., 1998) has gone furthest, with 19 descendants of its own.

How does its category compare?

All HIH devices

HIH Hysteroscope (And Accessories): FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · HIH

3in 2025

2007: 12008: 22009: 42010: 42011: 32012: 42013: 52014: 22015: 52016: 32017: 22018: 82019: 142020: 72021: 42022: 22023: 42024: 62025: 32026 (partial year): 7
2007high 14 (2019) · low 1 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · HIH

111in 2025

2009: 130 days median2010: 109 days median2011: 118 days median2012: 25 days median2013: 144 days median2015: 52 days median2016: 106 days median2018: 135 days median2019: 91 days median2020: 88 days median2021: 194 days median2023: 200 days median2024: 148 days median2025: 111 days median2026 (partial year): 168 days median
2007high 200 (2023) · low 25 (2012)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · HIH

3so far in 2026, the most since 2007

2019: 12023: 22026 (partial year): 3
2007high 3 (2026) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · HIH

1,698in 2025

2007: 72008: 122009: 172010: 312011: 592012: 782013: 1112014: 1252015: 2112016: 1722017: 3362018: 1822019: 2202020: 2532021: 1932022: 2892023: 1,4492024: 1,6112025: 1,698
2007high 1,698 (2025) · low 7 (2007)2025

MAUDE reports naming product code HIH, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20071—07
20082—012
20094130017
20104109031
20113118059
2012425078
201351440111
20142—0125
20155520211
201631060172
20172—0336
201881350182
201914911220
20207880253
202141940193
20222—0289
2023420021,449
2024614801,611
2025311101,698
202671683—

More from Richard Wolf Medical Instruments Corp.

146 FDA decisions under this applicant name. See the company

  • P870080/S002Hulka Clip for Tubal OcclusionRichard Wolf Medical Instruments Corp. · 2016
  • K151282core nova Complete Operating Room EndoscopyRichard Wolf Medical Instruments Corp. · 2016
  • K130423The Richard Wolf Endocam Logic HD Camera System 5525Richard Wolf Medical Instruments Corp. · 2013
  • K121724Endolight Led 1.1 Endolightled 1.2Richard Wolf Medical Instruments Corp. · 2012
  • K120898Keyport System, Includes: Keyport Silicone Sealing Insert 8850XXX Keyport Trucar 8850XX Keyport Trocar…Richard Wolf Medical Instruments Corp. · 2012

Recent decisions in HIH

The HIH category page

  • K254252UNIDRIVE SIII System; HOPKINS Telescope 0º (26205AMA) Operating Sheath (26205CD) Obturator (26205OC) Shaver…Karl Storz SE & CO. KG · 2026
  • K261102UNIDRIVE Select SystemKarl Storz SE & CO. KG · 2026
  • K254294Single-use Digital Hysteroscope (GYUT-A 12.6- 0, GYUT-A12.6- 12, GYUT-A 12.6- 22, GYUT-A 12.6- 30, GYUT-A…Zhejiang Geyi Medical Instrument Co., Ltd. · 2026
  • K260984HERizon RD5 Resecting Device (5FR1PK);HERizon RD5 Resecting Device - 5 pack (5FR5PK)Axora Medical, Inc. · 2026
  • K253020Strauss Surgical Resection InstrumentsAmerican Medical Endoscopy, Inc. · 2026

https://510kreport.com/device/K895857 · printed Nov 5, 2026

Cite this page

510(k) Report. “K895857: Continuous Irrigation Resectoscope Syst/Gynecology.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K895857

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Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026