510(k) Report

510(k) · Cleared

Cleared

Modification to:Laparoscopic/Endoscopic Instrument

K010779510(k) SpecialCleared Apr 10, 200126-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

Gibbons Surgical Corp. · FHO Pneumoperitoneum Needle

Cleared on Apr 10, 2001 after a 26-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

Decided
Apr 10, 2001
Review
26 days
Class
Class II
Product code
FHO
Recalls
None
Predicates
0

FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

FIG. 1 — Lineage of K010779Source: FDA 510(k) database · 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 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
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What was it cleared against?

FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

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.

How does its category compare?

All FHO devices

FHO Pneumoperitoneum Needle: FDA decisions, review times, recalls and adverse event reports over 20 years.

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—

More from Gibbons Surgical Corp.

2 FDA decisions under this applicant name. See the company

  • K012198Gibbons Sterile Trocar KitsGibbons Surgical Corp. · 2001

Recent decisions in FHO

The FHO category page

  • K172120Veress NeedleWickimed (Huizhou) Medical Equipment Manufacturing Co.,Ltd · 2017
  • K121370Vectec Disposable Pneumoperitoneum NeedleVectec · 2013
  • K970788Pneumo-Matic Insufflation NeedleApple Medical Corp. · 1997
  • K960574Argyle Turkel Neonatal/Pediatric Thoracic Catheter Insertion Tray and Thoracic Catheter SystemSherwood Medical Co. · 1996
  • K951894Access Expansion SystemMicro-Medical Devices, Inc. · 1995

https://510kreport.com/device/K010779 · printed Nov 4, 2026

Cite this page

510(k) Report. “K010779: Modification to:Laparoscopic/Endoscopic Instrument.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K010779

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