510(k) Report

510(k) · Cleared

Cleared

Oac (Optical Aspirating Curette)

K980096510(k) TraditionalCleared May 1, 1998112-day reviewClass I21 CFR 884.4530

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

Imagyn Medical Technologies, Inc. · HCY Curette, Uterine

Cleared on May 1, 1998 as substantially equivalent to K961688 (Imagyn Medical, Inc., 1996) and 2 other predicates after a 112-day review. Its family tree reaches back 1 generation to 1976.

Decided
May 1, 1998
Review
112 days
Class
Class I
Product code
HCY
Recalls
None
Predicates
3

Its longest line of descent runs back 1 generation to K760264 (1976). 3 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 1996: 1 other ancestor1988: 1 other ancestorK760264 · Curette, Proposed Tis-U-Trap, Metal · Milex Products, Inc. · 1976197519801985199019952000
Other ancestors, by generation 1 generation back: 2 other ancestors K760264 · Curette, Proposed Tis-U-Trap, Metal · Milex Products, Inc. · 19760
  1. Root · 1 generation backK760264 Curette, Proposed Tis-U-Trap, MetalMilex Products, Inc. · 1976
  2. This deviceK980096 Oac (Optical Aspirating Curette)Imagyn Medical Technologies, Inc. · 1998
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K760264Curette, Proposed Tis-U-Trap, MetalMilex Products, Inc.1976—
0 (this device)K980096Oac (Optical Aspirating Curette)Imagyn Medical Technologies, Inc.1998—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198810
199610
FIG. 1 — Lineage of K980096, 1976–1998Source: 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 HCY? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

  • Candidate predicates for a device like this, rankedin the report
  • Recall history across each candidate’s familyin the report
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What was it cleared against? (3)

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
*K961688Microspan Hysteroscope
Summary page 1
…ope portion of device), 21 C.F.R. §884.1690 III. Predicate Devices: The flexible fiberoptic hysteroscope component is similar to the MicroSpan Hysteroscope (510(k) No. K961688). The disposable curette component is similar to the Milex “Tis-U-Trap” Uterine Suction Curette, Milex, (510(k) No. K760264); an…
Imagyn Medical, Inc.1996—
*K760264Curette, Proposed Tis-U-Trap, Metal
Summary page 1
…ar to the MicroSpan Hysteroscope (510(k) No. K961688). The disposable curette component is similar to the Milex “Tis-U-Trap” Uterine Suction Curette, Milex, (510(k) No. K760264); and the Pipelle “Endometrial Suction Curette”, (510(k) No. K881456). IV. Description of the Device: Imagyn’s Optical Aspirat…
Milex Products, Inc.1976—
*K881456Pipelle DE Cornier Endometrial Suction Curette
Summary page 1
…e curette component is similar to the Milex “Tis-U-Trap” Uterine Suction Curette, Milex, (510(k) No. K760264); and the Pipelle “Endometrial Suction Curette”, (510(k) No. K881456). IV. Description of the Device: Imagyn’s Optical Aspirating Curette consists of a disposable aspirating curette intended to r…
Laboratoire Ccd C/O Washington Regulatory Services1988—

Also cleared against K961688: 3 other devices →

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 3 ancestors has a recall.
  • 3 other devices also cite its predicate K961688.

How does its category compare?

All HCY devices

HCY Curette, Uterine: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · HCY

FDA has decided no HCY device since 2007.

Median 510(k) review, days · HCY

Too few HCY 510(k)s in any year since 2007 to give a median.

Recalls per year · HCY

1in 2024

2024: 1
2007high 1 (2024) · low 0 (2007)2026

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

Adverse event reports per year · HCY

1in 2025

2007: 12009: 12010: 12013: 12018: 22019: 12020: 12021: 22022: 42023: 42024: 12025: 1
2007high 4 (2022) · low 0 (2008)2025

MAUDE reports naming product code HCY, 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
20070—01
20080—00
20090—01
20100—01
20110—00
20120—00
20130—01
20140—00
20150—00
20160—00
20170—00
20180—02
20190—01
20200—01
20210—02
20220—04
20230—04
20240—11
20250—01
20260—0—

What is it indicated for?

The Optical Aspirating Curette is indicated for use in visualizing the interior of the uterus and obtaining an endometrial tissue sample adequate for histological evaluation.

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

Also cleared against K961688

3 other devices cite the same predicate.

  • K123151Endosee Model 8000 U-ScopeEndosee Corp · 2013
  • K093218Femeye TwoFem Suite, LLC · 2010
  • K982630Medworks Visualization Insemination CatheterMedworks Corp. · 1999

More from Imagyn Medical Technologies, Inc.

7 FDA decisions under this applicant name. See the company

  • K032491Ecom CV4 Endotracheal Cardiac Output MonitorImagyn Medical Technologies, Inc. · 2003
  • K012706IM2001 Pulse OximeterImagyn Medical Technologies, Inc. · 2003
  • K010166Imagyn Isosleeve / Isostar Needle SystemImagyn Medical Technologies, Inc. · 2001
  • K991526Isostar I-125 Interstitial Seed, Model IS-12501Imagyn Medical Technologies, Inc. · 1999
  • K980291Impower External Vacuum SystemImagyn Medical Technologies, Inc. · 1998

Recent decisions in HCY

The HCY category page

  • K944238Endocyte TMD.L. Nelson and Assoc., Inc. · 1995
  • K935822Phase I CurettePhase I Corp. · 1994
  • K901442Baxter D & C TrayBaxter Healthcare Corp · 19901 recall
  • K890384Uterine CuretteKinetic Medical Products · 1989
  • K881794Ivory Finder SetIvory Instruments Co. · 1988

https://510kreport.com/device/K980096 · printed Nov 4, 2026

Cite this page

510(k) Report. “K980096: Oac (Optical Aspirating Curette).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K980096

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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