510(k) Report

510(k) · Cleared

Cleared

Endocoagulator Models 5, 8 & 20 Argon Laser

K870773510(k) TraditionalCleared Jul 10, 1987134-day reviewClass III

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

Hgm, Inc. · LLF Laser, Neurosurgical, Argon

Cleared on Jul 10, 1987 after a 134-day review. FDA has not posted a summary or statement for it, so its predicates are not known.

Decided
Jul 10, 1987
Review
134 days
Class
Class III
Product code
LLF
Recalls
None
Predicates
0

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

FIG. 1 — Lineage of K870773Source: 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 LLF? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

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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 LLF devices

LLF Laser, Neurosurgical, Argon: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · LLF

FDA has decided no LLF device since 2007.

Median 510(k) review, days · LLF

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

Recalls per year · LLF

No recall names LLF since 2007.

Adverse event reports per year · LLF

No MAUDE report names LLF since 2007.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—00
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 Hgm, Inc.

23 FDA decisions under this applicant name. See the company

  • K950120Smart PlugHgm, Inc. · 1995
  • K931072HGM Illuminating/Aspirating Endoocular ProbeHgm, Inc. · 1994
  • K931784HGM Illuminating Imaging Endocular ProbeHgm, Inc. · 1994
  • K933333HGM Scanman PlusHgm, Inc. · 1993
  • K931499Q-11 Ophthalmic LaserHgm, Inc. · 1993

Recent decisions in LLF

The LLF category page

  • K864610Cilas YM 101 ND:Yag Laser for Neurological UseInframed, Inc. · 1987
  • K860977Model 545-45 for Neurological Surgical ApplicationBritt Corp., Inc. · 1986
  • K833497Cooper Medical Model 770Cooper Medical Corp. · 1984

https://510kreport.com/device/K870773 · printed Nov 6, 2026

Cite this page

510(k) Report. “K870773: Endocoagulator Models 5, 8 & 20 Argon Laser.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K870773

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