510(k) Report

510(k) · Cleared

Cleared

Hemoclip X-20 Automatic Hemoclip Ligating Applier

K844836510(k) TraditionalCleared Jan 23, 198542-day reviewClass II21 CFR 866.3220

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

Edward Weck, Inc. · GWD Indirect Fluorescent Antibody Test, Entamoeba Histolytica & Rel Sp

Cleared on Jan 23, 1985 after a 42-day review. FDA has not posted a summary or statement for it, so its predicates are not known.

Decided
Jan 23, 1985
Review
42 days
Class
Class II
Product code
GWD
Recalls
None
Predicates
0

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

FIG. 1 — Lineage of K844836Source: 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 GWD? 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 GWD devices

GWD Indirect Fluorescent Antibody Test, Entamoeba Histolytica & Rel Sp: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · GWD

FDA has decided no GWD device since 2007.

Median 510(k) review, days · GWD

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

Recalls per year · GWD

1in 2007

2007: 1
2007high 1 (2007) · low 0 (2008)2026

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

Adverse event reports per year · GWD

No MAUDE report names GWD since 2007.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—10
20080—00
20090—00
20100—00
20110—00
20120—00
20130—00
20140—00
20150—00
20160—00
20170—00
20180—00
20190—00
20200—00
20210—00
20220—00
20230—00
20240—00
20250—00
20260—0—

More from Edward Weck, Inc.

140 FDA decisions under this applicant name. See the company

  • K915378Weck TrocarEdward Weck, Inc. · 1992
  • K914690LM15(TM), Catalog Number - 523821Edward Weck, Inc. · 1992
  • K911915Hemoclip IIEdward Weck, Inc. · 1992
  • K914470Pneumo-Seal (TM)Edward Weck, Inc. · 1991
  • K911272Endoscopic Needlholder Cat. Number 114705Edward Weck, Inc. · 1991

Recent decisions in GWD

The GWD category page

  • K873299Merifluor (TM)-GiardiaMeridian Diagnostics, Inc. · 1987

https://510kreport.com/device/K844836 · printed Nov 6, 2026

Cite this page

510(k) Report. “K844836: Hemoclip X-20 Automatic Hemoclip Ligating Applier.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K844836

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