510(k) Report

510(k) · Cleared

Cleared

Ambient HipVac 50 Wand with Integrated Finger Switches

K161481510(k) TraditionalCleared Oct 21, 2016143-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

ArthroCare Corporation · GEI Electrosurgical, Cutting & Coagulation & Accessories

Cleared on Oct 21, 2016 after a 143-day review. The FDA summary names no predicate by number. 2 later devices descend from it.

Decided
Oct 21, 2016
Review
143 days
Class
Class II
Product code
GEI
Recalls
None
Predicates
0

2 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 2022: 1 descendant cleared2025: 1 descendant cleared201620182020202220242026
  1. This deviceK161481 Ambient HipVac 50 Wand with Integrated Finger SwitchesArthroCare Corporation · 2016
  2. Descendant · cites it directly · 1 of its ownK220563 Ambient HipVac 50 Wand with Integrated Finger Switches, RF20000…ArthroCare Corporation · 2022
  3. Descendant · 2 generations on · 0 of its ownK242907 DELPHI SystemCnS Medical Co., Ltd. · 2025

Most influential descendants

Showing 2 of 2 · See all
  • K220563Ambient HipVac 50 Wand with Integrated Finger Switches, RF20000 COBLATION System…ArthroCare Corporation · 2022 · cites it directly1descendant
  • K242907DELPHI SystemCnS Medical Co., Ltd. · 2025 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K161481Ambient HipVac 50 Wand with Integrated Finger SwitchesArthroCare Corporation2016—
+1K220563Ambient HipVac 50 Wand with Integrated Finger Switches, RF20000 COBLATION…ArthroCare Corporation2022—
+2K242907DELPHI SystemCnS Medical Co., Ltd.2025—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
202210
202510
FIG. 1 — Lineage of K161481, 2016–2025Source: FDA 510(k) summaries, read by 510(k) Report · 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), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in GEI? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new GEI device

  1. #1 K231790 The InMode System with the Morpheus8 Applicatorsscore 32.7 · 21 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against?

The FDA summary names no predicate by number.

What descends from it? (2)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K220563Ambient HipVac 50 Wand with Integrated Finger Switches, RF20000 COBLATION System…ArthroCare Corporation20221

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.

What does this lineage say?

  • Of its descendants, K220563 (ArthroCare Corporation, 2022) has gone furthest, with 1 descendant of its own.

How does its category compare?

All GEI devices

GEI Electrosurgical, Cutting & Coagulation & Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, this device’s year, is highlighted.

FDA decisions per year · GEI

52in 2025

2007: 502008: 612009: 422010: 462011: 352012: 392013: 482014: 492015: 472016: 642017: 522018: 472019: 482020: 592021: 462022: 552023: 652024: 592025: 522026 (partial year): 43
2007high 65 (2023) · low 35 (2011)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · GEI

113in 2025

2007: 51 days median2008: 71 days median2009: 130 days median2010: 109 days median2011: 135 days median2012: 133 days median2013: 136 days median2014: 103 days median2015: 123 days median2016: 108 days median2017: 72 days median2018: 93 days median2019: 93 days median2020: 105 days median2021: 146 days median2022: 150 days median2023: 104 days median2024: 125 days median2025: 113 days median2026 (partial year): 183 days median
2007high 183 (2026) · low 51 (2007)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · GEI

4in 2025

2007: 212008: 192009: 272010: 512011: 322012: 302013: 132014: 32015: 42016: 32017: 22018: 62019: 52020: 12021: 62022: 492023: 27, 4 Class I2024: 22, 10 Class I2025: 42026 (partial year): 8
2007high 51 (2010) · low 1 (2020)2026

Class I (14 since 2007) Class II/III not classified

Adverse event reports per year · GEI

7,592in 2025

2007: 2,7952008: 2,5562009: 3,5912010: 3,3772011: 4,4632012: 5,2162013: 4,8972014: 4,9082015: 4,9362016: 5,6162017: 6,0732018: 6,5452019: 7,0672020: 6,4902021: 6,3542022: 6,1032023: 7,1762024: 7,8972025: 7,592
2007high 7,897 (2024) · low 2,556 (2008)2025

MAUDE reports naming product code GEI, 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
20075051212,795
20086171192,556
200942130273,591
201046109513,377
201135135324,463
201239133305,216
201348136134,897
20144910334,908
20154712344,936
20166410835,616
2017527226,073
2018479366,545
2019489357,067
20205910516,490
20214614666,354
202255150496,103
20236510427 (4)7,176
20245912522 (10)7,897
20255211347,592
2026431838—

What is it indicated for?

The Ambient HipVac 50 Wand with Integrated Finger Switches is indicated for resection and ablation of soft tissue, and hemostasis of blood vessels less than 1 mm (via coagulation) in the following arthroscopic and orthopedic procedures: Joint | Ablation/Debridement | Excision/Resection All Joints (Hip, Knee, Shoulder, Wrist, Ankle, Elbow) | Articular Cartilage; Bursectomy; Chondroplasty; Fascia; Ligament; Scar Tissue; Soft Tissue; Synovectomy; Tendon |…

Read the full statement (117 words)

The Ambient HipVac 50 Wand with Integrated Finger Switches is indicated for resection and ablation of soft tissue, and hemostasis of blood vessels less than 1 mm (via coagulation) in the following arthroscopic and orthopedic procedures:

Joint | Ablation/Debridement | Excision/Resection

All Joints (Hip, Knee, Shoulder, Wrist, Ankle, Elbow) | Articular Cartilage; Bursectomy; Chondroplasty; Fascia; Ligament; Scar Tissue; Soft Tissue; Synovectomy; Tendon | Articular Labrum; Capsule; Cysts; Ligament; Loose Bodies; Plica Removal; Scar Tissue; Soft Tissue; Synovial Membrane; Tendon

Hip | | Acetabular Labrum

Knee | ACL/PCL; Notchplasty | Capsular Release; Cartilage Flaps; Discoid Meniscus; Lateral Release; Meniscal Cystectomy; Meniscectomy; Villusectomy

Shoulder | Acromioplasty; Subacromial Decompression | Frozen Shoulder Release; Glenoid Labrum

Wrist | | Triangular Fibrocartilage

Indications for use as stated in the FDA summary.

More from ArthroCare Corporation

37 FDA decisions under this applicant name. See the company

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https://510kreport.com/device/K161481 · printed Nov 6, 2026

Cite this page

510(k) Report. “K161481: Ambient HipVac 50 Wand with Integrated Finger Switches.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K161481

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Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026