510(k) Report

510(k) · Cleared

Cleared

Pipelle DE Cornier Endometrial Suction Curette

K881456510(k) TraditionalCleared Oct 14, 1988191-day reviewClass II21 CFR 884.1175

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

Laboratoire Ccd C/O Washington Regulatory Services · HHK Curette, Suction, Endometrial (And Accessories)

Cleared on Oct 14, 1988 after a 191-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 6 later devices descend from it.

Decided
Oct 14, 1988
Review
191 days
Class
Class II
Product code
HHK
Recalls
None
Predicates
0

6 later devices descend from it, 2 citing it directly.

Descendants, by year cleared 1998: 1 descendant cleared2008: 1 descendant cleared2017: 1 descendant cleared2012: 1 descendant cleared2014: 1 descendant cleared2024: 1 descendant cleared1990200020102020
  1. This deviceK881456 Pipelle DE Cornier Endometrial Suction CuretteLaboratoire Ccd C/O Washington Regulatory Services · 1988
  2. Descendant · cites it directly · 4 of its ownK082066 Tao Brush I.U.M.C. Endometrial SamplerCook Urological, Inc. · 2008 · Recalled
  3. Descendant · 2 generations on · 1 of its ownK170603 Tao Brush I.U.M.C. Endometrial SamplerCook Incorporated · 2017
  4. Descendant · 3 generations on · 0 of its ownK240595 Utepreva Endometrial Sampler (UP01)Utepreva, LLC · 2024
  5. Descendant · 2 generations on · 0 of its ownK133144 Sonosure Sonohysterography & Endometrial Sampling DeviceCrossbay Medical, Inc. · 2014
  6. Descendant · 2 generations on · 0 of its ownK112763 Matrixbrush Endometrial SamplerPost Oak Innovations, Inc. · 2012

Showing 5 of 6 descendants. See all descendants

Descendants cleared per year

1998: 12008: 12012: 12014: 12017: 12024: 1
1998high 1 (1998) · low 0 (1999)2026

Most influential descendants

Showing 5 of 6 · See all
  • K082066Tao Brush I.U.M.C. Endometrial SamplerCook Urological, Inc. · 2008 · cites it directly4descendants
  • K170603Tao Brush I.U.M.C. Endometrial SamplerCook Incorporated · 2017 · 2 generations on1descendant
  • K240595Utepreva Endometrial Sampler (UP01)Utepreva, LLC · 2024 · 3 generations on0descendants
  • K133144Sonosure Sonohysterography & Endometrial Sampling DeviceCrossbay Medical, Inc. · 2014 · 2 generations on0descendants
  • K112763Matrixbrush Endometrial SamplerPost Oak Innovations, Inc. · 2012 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K881456Pipelle DE Cornier Endometrial Suction CuretteLaboratoire Ccd C/O Washington Regulatory Services1988—
+1K082066Tao Brush I.U.M.C. Endometrial SamplerCook Urological, Inc.20081
+2K170603Tao Brush I.U.M.C. Endometrial SamplerCook Incorporated2017—
+3K240595Utepreva Endometrial Sampler (UP01)Utepreva, LLC2024—
+2K133144Sonosure Sonohysterography & Endometrial Sampling DeviceCrossbay Medical, Inc.2014—
+2K112763Matrixbrush Endometrial SamplerPost Oak Innovations, Inc.2012—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199810
200810
201210
201410
201710
202410
FIG. 1 — Lineage of K881456, 1988–2024Source: 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 HHK? 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 HHK device

  1. #1 K251882 Uterine Aspiration Setscore 10.5 · 2 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? (6)

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K082066Tao Brush I.U.M.C. Endometrial SamplerCook Urological, Inc.20084
K980096Oac (Optical Aspirating Curette)Imagyn Medical Technologies, Inc.19980

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, K082066 (Cook Urological, Inc., 2008) has gone furthest, with 4 descendants of its own.

How does its category compare?

All HHK devices

HHK Curette, Suction, Endometrial (And Accessories): FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · HHK

1in 2025

2010: 12011: 12020: 22024: 12025: 1
2007high 2 (2020) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · HHK

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

Recalls per year · HHK

1in 2022

2014: 22022: 1
2007high 2 (2014) · low 0 (2007)2026

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

Adverse event reports per year · HHK

9in 2025

2008: 22013: 12015: 22016: 12017: 22018: 12019: 42021: 12022: 22023: 12024: 42025: 9
2007high 9 (2025) · low 0 (2007)2025

MAUDE reports naming product code HHK, 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—00
20080—02
20090—00
20101—00
20111—00
20120—00
20130—01
20140—20
20150—02
20160—01
20170—02
20180—01
20190—04
20202—00
20210—01
20220—12
20230—01
20241—04
20251—09
20260—0—
Cite this page

510(k) Report. “K881456: Pipelle DE Cornier Endometrial Suction Curette.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K881456

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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