510(k) Report

510(k) · Cleared

Cleared

Hand-Trol S

K931215510(k) TraditionalCleared Mar 28, 1994383-day reviewClass II21 CFR 878.4400

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

Aspen Labs · DWG Electrosurgical Device

Cleared on Mar 28, 1994 after a 383-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

Decided
Mar 28, 1994
Review
383 days
Class
Class II
Product code
DWG
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 K931215Source: 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 DWG? 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 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 DWG devices

DWG Electrosurgical Device: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · DWG

FDA has decided no DWG device since 2007.

Median 510(k) review, days · DWG

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

Recalls per year · DWG

No recall names DWG since 2007.

Adverse event reports per year · DWG

6in 2024

2010: 52012: 132013: 1222014: 842015: 92017: 22018: 12023: 52024: 6
2007high 122 (2013) · low 0 (2007)2025

MAUDE reports naming product code DWG, 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—05
20110—00
20120—013
20130—0122
20140—084
20150—09
20160—00
20170—02
20180—01
20190—00
20200—00
20210—00
20220—00
20230—05
20240—06
20250—00
20260—0—

More from Aspen Labs

6 FDA decisions under this applicant name. See the company

  • K970493Hyfrecator 2000Aspen Labs · 19971 recall
  • K925333Single Use Tungsten Wire Lee Loop ElectrodeAspen Labs · 1994
  • K912046Single Use Lee ElectrodeAspen Labs · 1992
  • K905654Electrosurgical Unit with AccessoriesAspen Labs · 1991
  • K904240Single Use Laparscopic ElectrodeAspen Labs · 1991

Recent decisions in DWG

The DWG category page

  • K942823Mahe InstrumentsMahe Intl., Inc. · 1994
  • K932345Tech-Switch Electrosurgical Pencil, Single UseConmedcorp · 1994
  • K925708Disposable Electrosurgery Ball ElectrodeBeacon Laboratories, Inc. · 1993

https://510kreport.com/device/K931215 · printed Nov 4, 2026

Cite this page

510(k) Report. “K931215: Hand-Trol S.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K931215

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