510(k) Report

510(k) · Cleared

Cleared

Surgitron

K955158510(k) TraditionalCleared Feb 9, 199688-day reviewClass II21 CFR 886.4100

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

Ellman Intl., Inc. · HQR Apparatus, Cautery, Radiofrequency, Ac-Powered

Cleared on Feb 9, 1996 after an 88-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

Decided
Feb 9, 1996
Review
88 days
Class
Class II
Product code
HQR
Recalls
None
Predicates
0

FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

FIG. 1 — Lineage of K955158Source: 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.

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What was it cleared against?

FDA lists a 510(k) statement for it but has not posted the file, 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 HQR devices

HQR Apparatus, Cautery, Radiofrequency, Ac-Powered: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · HQR

FDA has decided no HQR device since 2007.

Median 510(k) review, days · HQR

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

Recalls per year · HQR

No recall names HQR since 2007.

Adverse event reports per year · HQR

3in 2024

2008: 12010: 12011: 52013: 12014: 12015: 42016: 12017: 12018: 32020: 12021: 22022: 12024: 3
2007high 5 (2011) · low 0 (2007)2025

MAUDE reports naming product code HQR, 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—01
20090—00
20100—01
20110—05
20120—00
20130—01
20140—01
20150—04
20160—01
20170—01
20180—03
20190—00
20200—01
20210—02
20220—01
20230—00
20240—03
20250—00
20260—0—

More from Ellman Intl., Inc.

15 FDA decisions under this applicant name. See the company

  • K013255Surgitron 120 Iec (Also Known as Surgitron 4.0 Dual RFEllman Intl., Inc. · 2001
  • K003126Bipolar Trigger-Flex ProbeEllman Intl., Inc. · 2001
  • K001986Surgitron Iec IIEllman Intl., Inc. · 2000
  • K001407Surgitron Iec IIEllman Intl., Inc. · 2000
  • K001253Surgitron Iec IIEllman Intl., Inc. · 2000

Recent decisions in HQR

The HQR category page

  • K050308Thermal Cautery ProbeStarion Instruments · 2005
  • K990064DI-Rhex Ophthalmic Diathermy SystemOphthalmic Technologies, Inc. · 1999
  • K980522Refractec MCS-100Refractec, Inc. · 1998
  • K972749Pao Bipolar Coaxial Coagulator (55-P15C/55-P18C/55-P18S/55-P19S/55-P20S)C.M. Chance, Ltd. · 1998
  • K952151Storz Ophthalmic Bipolar Cautery Instruments (D8200, D8201, D8203) and Bipolar Cords (D8202, D8204)Storz · 1996

https://510kreport.com/device/K955158 · printed Nov 4, 2026

Cite this page

510(k) Report. “K955158: Surgitron.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K955158

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