510(k) Report

510(k) · Cleared

Cleared

Endopath Disposable Pneumoperitoneum Needle

K910875510(k) TraditionalCleared Mar 19, 199118-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

ETHICON, Inc. · FDP Apparatus, Pneumoperitoneum, Automatic

Cleared on Mar 19, 1991 after an 18-day review. FDA has not posted a summary or statement for it, so its predicates are not known.

Decided
Mar 19, 1991
Review
18 days
Class
Class II
Product code
FDP
Recalls
None
Predicates
0

FDA has not posted a summary or statement for it, so its predicates are not known.

FIG. 1 — Lineage of K910875Source: 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 FDP? 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 has not posted a summary or statement for it, 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 FDP devices

FDP Apparatus, Pneumoperitoneum, Automatic: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · FDP

FDA has decided no FDP device since 2007.

Median 510(k) review, days · FDP

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

Recalls per year · FDP

No recall names FDP since 2007.

Adverse event reports per year · FDP

16in 2025

2009: 232010: 142011: 22012: 22013: 12014: 12015: 112016: 22017: 22019: 22020: 32021: 12022: 72023: 62024: 222025: 16
2007high 23 (2009) · low 0 (2007)2025

MAUDE reports naming product code FDP, 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—00
20090—023
20100—014
20110—02
20120—02
20130—01
20140—01
20150—011
20160—02
20170—02
20180—00
20190—02
20200—03
20210—01
20220—07
20230—06
20240—022
20250—016
20260—0—

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https://510kreport.com/device/K910875 · printed Nov 5, 2026

Cite this page

510(k) Report. “K910875: Endopath Disposable Pneumoperitoneum Needle.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K910875

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