510(k) Report

510(k) · Cleared

Cleared

Cotton Filled Gauze Sponges 2 X 2

K861727510(k) TraditionalCleared Jul 10, 198665-day reviewClass I21 CFR 872.6050

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

Cross Country Paper Products Corp. · EFN Cotton, Roll

Cleared on Jul 10, 1986 after a 65-day review. FDA has not posted a summary or statement for it, so its predicates are not known.

Decided
Jul 10, 1986
Review
65 days
Class
Class I
Product code
EFN
Recalls
None
Predicates
0

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

FIG. 1 — Lineage of K861727Source: 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 EFN? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

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  • 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 EFN devices

EFN Cotton, Roll: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · EFN

FDA has decided no EFN device since 2007.

Median 510(k) review, days · EFN

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

Recalls per year · EFN

No recall names EFN since 2007.

Adverse event reports per year · EFN

1in 2018

2010: 22015: 22018: 1
2007high 2 (2010) · low 0 (2007)2025

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

More from Cross Country Paper Products Corp.

3 FDA decisions under this applicant name. See the company

  • K941327Crosstex Self-Sealing Sterilization PouchCross Country Paper Products Corp. · 19941 recall
  • K844759Surgical Scalpel Blades & DisposablesCross Country Paper Products Corp. · 1985

Recent decisions in EFN

The EFN category page

  • K872810Strung Dental RollsAmerican Silk Sutures, Inc. · 19871 recall
  • K871464Medgroup Enterprises Cotton Gauze Sponges-Non SterMedgroup Enterprises, Inc. · 1987
  • K863764Cotton Rolls, Non-SterileThe Medical Group, Inc. · 19862 recalls
  • K861338Dental Cotton Rolls, Sterile and Non-SterileIntl. Verbandstoff-Fabrik Schaffhau · 1986
  • K843539Teledyne Densco Dry Tips Saliva Absorb-Molnlycke A/S Hospital Products · 1985

https://510kreport.com/device/K861727 · printed Nov 4, 2026

Cite this page

510(k) Report. “K861727: Cotton Filled Gauze Sponges 2 X 2.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K861727

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