510(k) Report

510(k) · Cleared

Cleared

Galileo Disposable Hysteroscopes

K981828510(k) TraditionalCleared Jul 7, 199846-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

Netoptix Corp. · HIH Hysteroscope (And Accessories)

Cleared on Jul 7, 1998 as substantially equivalent to K974297 (Netoptix Corp., 1998) and 4 other predicates after a 46-day review. Its family tree reaches back 2 generations to 1977.

Decided
Jul 7, 1998
Review
46 days
Class
Class II
Product code
HIH
Recalls
None
Predicates
5

Its longest line of descent runs back 2 generations to K770378 (1977). 5 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 1996: 1 other ancestor1994: 1 other ancestor1988: 1 other ancestorK770378 · Laparoscope, Fiber Light, Palmer-Jacobs · Richard Wolf Medical Instruments Corp. · 1977K974297 · Galileo Disposable Hysteroscopes · Netoptix Corp. · 1998197519801985199019952000
Other ancestors, by generation 1 generation back: 3 other ancestors K974297 · Galileo Disposable Hysteroscopes · Netoptix Corp. · 1998K770378 · Laparoscope, Fiber Light, Palmer-Jacobs · Richard Wolf Medical Instruments Corp. · 19770
  1. Root · 2 generations backK770378 Laparoscope, Fiber Light, Palmer-JacobsRichard Wolf Medical Instruments Corp. · 1977
  2. 1 generation backK974297 Galileo Disposable HysteroscopesNetoptix Corp. · 1998
  3. This deviceK981828 Galileo Disposable HysteroscopesNetoptix Corp. · 1998
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−2K770378Laparoscope, Fiber Light, Palmer-JacobsRichard Wolf Medical Instruments Corp.1977—
−1K974297Galileo Disposable HysteroscopesNetoptix Corp.1998—
0 (this device)K981828Galileo Disposable HysteroscopesNetoptix Corp.1998—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198810
199410
199610
FIG. 1 — Lineage of K981828, 1977–1998Source: 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), 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. #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? (5)

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.

TypeNumberDeviceApplicantDecidedRecalls
*K974297Galileo Disposable Hysteroscopes
Summary page 1
…KETED DEVICE(S) The Galileo Hysteroscopes are substantially equivalent to several legally marketed endoscopes including the Galileo Disposable Diagnostic Hysteroscopes (K974297), Galileo Reusable Hysteroscopes (K962116), U.S. Surgical Surgiview Endoscopes, (K925968) and the Richard Wolf Hysteroscopes and…
Netoptix Corp.1998—
*K962116Galileo Endoscopes
Summary page 1
…are substantially equivalent to several legally marketed endoscopes including the Galileo Disposable Diagnostic Hysteroscopes (K974297), Galileo Reusable Hysteroscopes (K962116), U.S. Surgical Surgiview Endoscopes, (K925968) and the Richard Wolf Hysteroscopes and Laparoscopes (K880314 and K770378). | Gal…
Galileo Electro-Optics Corp.1996—
*K925968Endoscope
Summary page 1
…y marketed endoscopes including the Galileo Disposable Diagnostic Hysteroscopes (K974297), Galileo Reusable Hysteroscopes (K962116), U.S. Surgical Surgiview Endoscopes, (K925968) and the Richard Wolf Hysteroscopes and Laparoscopes (K880314 and K770378). | Galileo Corporation 510(k) 5/20/98 Galileo Disposa…
United States Surgical, A Division of Tyco Healthc1994—
*K880314Hysteroscope Autonom 4992
Summary page 1
…tic Hysteroscopes (K974297), Galileo Reusable Hysteroscopes (K962116), U.S. Surgical Surgiview Endoscopes, (K925968) and the Richard Wolf Hysteroscopes and Laparoscopes (K880314 and K770378). | Galileo Corporation 510(k) 5/20/98 Galileo Disposable Hysteroscopes Page D-1 IKG &)Ly oM 4. DEV…
Richard Wolf Medical Instruments Corp.1988—
*K770378Laparoscope, Fiber Light, Palmer-Jacobs
Summary page 1
…copes (K974297), Galileo Reusable Hysteroscopes (K962116), U.S. Surgical Surgiview Endoscopes, (K925968) and the Richard Wolf Hysteroscopes and Laparoscopes (K880314 and K770378). | Galileo Corporation 510(k) 5/20/98 Galileo Disposable Hysteroscopes Page D-1 IKG &)Ly oM 4. DEVICE DESCRIPT…
Richard Wolf Medical Instruments Corp.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 21 years and passes through 2 companies; a new generation was cleared every 20.9 years on median.
  • None of the 5 ancestors has a recall.

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—

What is it indicated for?

The Galileo Disposable Hysteroscopes are endoscopes intended for visualization of the cervical canal and uterine cavity for diagnostic and surgical procedures during gynecological procedures. The Hysteroscope diagnostic indications include abnormal uterine bleeding, infertility and pregnancy wastage, evaluation of abnormal hysterosalpingogram, intrauterine foreign body, amenorrhea and pelvic pain. The Hysteroscope is indicated for surgical procedures such as directed biopsy, removal of submucous fibroids and large polyps, submucous myomectomy, transection of intrauterine adhesions and septa and endometrial ablation.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

More from Netoptix Corp.

4 FDA decisions under this applicant name. See the company

  • K981958Leisegang Video ColposcopeNetoptix Corp. · 1998
  • K974297Galileo Disposable HysteroscopesNetoptix Corp. · 1998
  • K971896Galileo High Resolution Micro CouplerNetoptix Corp. · 1997

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/K981828 · printed Nov 4, 2026

Cite this page

510(k) Report. “K981828: Galileo Disposable Hysteroscopes.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K981828

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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