510(k) Report

510(k) · Cleared

Cleared

Extended Covers, Sterile

K892069510(k) TraditionalCleared Aug 8, 1989130-day reviewClass I21 CFR 876.1075

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

Amedic USA · FFF Cover, Biopsy Forceps

Cleared on Aug 8, 1989 after a 130-day review. FDA has not posted a summary or statement for it, so its predicates are not known.

Decided
Aug 8, 1989
Review
130 days
Class
Class I
Product code
FFF
Recalls
None
Predicates
0

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

FIG. 1 — Lineage of K892069Source: FDA 510(k) database · 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), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in FFF? 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?

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 FFF devices

FFF Cover, Biopsy Forceps: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · FFF

FDA has decided no FFF device since 2007.

Median 510(k) review, days · FFF

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

Recalls per year · FFF

2in 2018

2007: 32018: 2
2007high 3 (2007) · low 0 (2008)2026

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

Adverse event reports per year · FFF

2in 2016

2009: 12011: 12013: 12016: 2
2007high 2 (2016) · low 0 (2007)2025

MAUDE reports naming product code FFF, 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—30
20080—00
20090—01
20100—00
20110—01
20120—00
20130—01
20140—00
20150—00
20160—02
20170—00
20180—20
20190—00
20200—00
20210—00
20220—00
20230—00
20240—00
20250—00
20260—0—

More from Amedic USA

10 FDA decisions under this applicant name. See the company

  • K897120Equip Covers, SterileAmedic USA · 1990
  • K892070General Ivt Needle Guide Kit, SterileAmedic USA · 1989
  • K892071General (Biopsy) Needle Guide Kit, SterileAmedic USA · 1989
  • K892068TRT (Acuson) Needle Guide Kit, SterileAmedic USA · 1989
  • K871467Biopsy Needle Guide Kit, SterileAmedic USA · 1987

https://510kreport.com/device/K892069 · printed Nov 5, 2026

Cite this page

510(k) Report. “K892069: Extended Covers, Sterile.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K892069

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
  • Page last updated Nov 3, 2026