510(k) Report

510(k) · Cleared

Cleared

Veress Needle

K172120510(k) TraditionalCleared Sep 14, 201763-day reviewClass II21 CFR 876.1500

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

Wickimed (Huizhou) Medical Equipment Manufacturing Co.,Ltd · FHO Pneumoperitoneum Needle

Cleared on Sep 14, 2017 as substantially equivalent to K150068 (Unimicro Medical Systems (Shenzhen) Co., Ltd., 2015) after a 63-day review. Its family tree reaches back 3 generations to 2000. 2 later devices descend from it.

Decided
Sep 14, 2017
Review
63 days
Class
Class II
Product code
FHO
Recalls
None
Predicates
1

Its longest line of descent runs back 3 generations to K993625 (2000). 2 later devices descend from it, 1 citing it directly.

  1. Root · 3 generations backK993625 Insufflation Needle- 120MM, Model 900-200Genicon, LC · 2000
  2. 2 generations backK111441 Unimax Veress NeedleUnimax Medical Systems, Inc. · 2011
  3. 1 generation backK150068 Unimicro Veress NeedleUnimicro Medical Systems (Shenzhen) Co., Ltd. · 2015
  4. This deviceK172120 Veress NeedleWickimed (Huizhou) Medical Equipment Manufacturing Co.,Ltd · 2017
  5. Descendant · cites it directly · 1 of its ownK193339 GTK Veress NeedlesGuangzhou T.K Medical Instrument Co., Ltd. · 2020
  6. Descendant · 2 generations on · 0 of its ownK231407 StarFinPremium Medical Technology, LLC · 2023

Most influential descendants

Showing 2 of 2 · See all
  • K193339GTK Veress NeedlesGuangzhou T.K Medical Instrument Co., Ltd. · 2020 · cites it directly1descendant
  • K231407StarFinPremium Medical Technology, LLC · 2023 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−3K993625Insufflation Needle- 120MM, Model 900-200Genicon, LC2000—
−2K111441Unimax Veress NeedleUnimax Medical Systems, Inc.2011—
−1K150068Unimicro Veress NeedleUnimicro Medical Systems (Shenzhen) Co., Ltd.2015—
0 (this device)K172120Veress NeedleWickimed (Huizhou) Medical Equipment Manufacturing Co.,Ltd2017—
+1K193339GTK Veress NeedlesGuangzhou T.K Medical Instrument Co., Ltd.2020—
+2K231407StarFinPremium Medical Technology, LLC2023—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
202010
202310
FIG. 1 — Lineage of K172120, 2000–2023Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

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 FHO? 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
Get a 510(k) Report

What was it cleared against? (1)

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
*K150068Unimicro Veress Needle
Summary page 5
…R Veress Needle Systems HIF 884.1730 K150068 Needle (ShenZhen) Co., Class II, 21CFR Ltd.…
Unimicro Medical Systems (Shenzhen) Co., Ltd.2015—

Also cleared against K150068: 1 other device →

What descends from it? (2)

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

NumberDeviceApplicantDecidedDescendants
K193339GTK Veress NeedlesGuangzhou T.K Medical Instrument Co., Ltd.20201

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 17 years and passes through 4 companies; a new generation was cleared every 3.9 years on median.
  • None of the 3 ancestors has a recall.
  • Of its descendants, K193339 (Guangzhou T.K Medical Instrument Co., Ltd., 2020) has gone furthest, with 1 descendant of its own.
  • 1 other device also cites its predicate K150068.

How does its category compare?

All FHO devices

FHO Pneumoperitoneum Needle: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, this device’s year, is highlighted.

FDA decisions per year · FHO

1in 2017

2013: 12017: 1
2007high 1 (2013) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · FHO

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

Recalls per year · FHO

No recall names FHO since 2007.

Adverse event reports per year · FHO

1in 2025

2007: 22008: 12011: 12012: 12013: 12017: 102018: 22019: 32020: 52021: 62022: 42024: 52025: 1
2007high 10 (2017) · low 0 (2009)2025

MAUDE reports naming product code FHO, 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—02
20080—01
20090—00
20100—00
20110—01
20120—01
20131—01
20140—00
20150—00
20160—00
20171—010
20180—02
20190—03
20200—05
20210—06
20220—04
20230—00
20240—05
20250—01
20260—0—

What is it indicated for?

The Veress Needle is intended for percutaneous insertion into the peritoneal cavity for the purpose of insufflation with carbon dioxide to establish pneumoperitoneum prior to the placement of trocars during laparoscopic procedures.

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

Cite this page

510(k) Report. “K172120: Veress Needle.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K172120

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

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