510(k) Report

FDA product code · Obstetrics and gynecology

Coagulator, Laparoscopic, Unipolar (And Accessories)

HFGClass II21 CFR 884.4160510(k) required11 decisions since 19900 recalls

11 FDA decisions since 1990. No recall names this code. The most-cited predicate is K121858, named by 3 later devices.

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

FIG. A — Illustration, obstetrics and gynecology panel

Twenty years of HFG at a glance: how often FDA decides these devices, how long 510(k) reviews take, how often they are recalled, and how many adverse event reports name the code.

FDA decisions per year · HFG

1in 2018

2010: 12012: 12014: 22018: 1
2007high 2 (2014) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · HFG

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

Recalls per year · HFG

No recall names HFG since 2007.

Adverse event reports per year · HFG

32in 2025

2007: 22009: 22010: 22014: 32015: 22016: 52017: 22018: 32019: 52020: 62021: 202022: 202023: 362024: 212025: 32
2007high 36 (2023) · low 0 (2008)2025

MAUDE reports naming product code HFG, 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—02
20080—00
20090—02
20101—02
20110—00
20121—00
20130—00
20142—03
20150—02
20160—05
20170—02
20181—03
20190—05
20200—06
20210—020
20220—020
20230—036
20240—021
20250—032
20260—0—
FIG. 1 — HFG by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in HFG? A 510(k) Report ranks candidate predicates in this code by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which predicates do HFG devices cite most?

Devices in this code that later submissions most often claim equivalence to.

  • K121858The Ablation SystemHalt Medical, Inc. · 20123cite it
  • K132744Acessa Guidance SystemHalt Medical, Inc. · 20141cites it
  • K991424Insulscan Insulation Testing SystemMedicor Corp. · 19991cites it

Which HFG devices have the deepest lineage?

Devices in this code with the longest line of descent behind them.

  • K181124Acessa ProVu SystemAcessa Health, Inc. · 201816generations
  • K132744Acessa Guidance SystemHalt Medical, Inc. · 20144generations
  • K132184Acessa Guidance HandpieceHalt Medical, Inc. · 20143generations
  • K121858The Ablation SystemHalt Medical, Inc. · 20122generations
  • K101606Micromed PD-8K Insulation Defect DetectorMcgan Technology, LLC · 20102generations
  • K991424Insulscan Insulation Testing SystemMedicor Corp. · 19991generation

What has FDA decided in HFG lately?

  • K181124Acessa ProVu SystemAcessa Health, Inc. · 2018
  • K132744Acessa Guidance SystemHalt Medical, Inc. · 2014
  • K132184Acessa Guidance HandpieceHalt Medical, Inc. · 2014
  • K121858The Ablation SystemHalt Medical, Inc. · 2012
  • K101606Micromed PD-8K Insulation Defect DetectorMcgan Technology, LLC · 2010
  • K991424Insulscan Insulation Testing SystemMedicor Corp. · 1999

All 11 HFG decisions →

Related product codes

Other codes under 21 CFR 884.4160.

KNF Coagulator-Cutter, Endoscopic, Unipolar (And…HFH Coagulator, Hysteroscopic (And Accessories)HFI Coagulator, Culdoscopic (And Accessories)