510(k) Report

510(k) · Cleared

Recalled · 2004

Tissuelink Bipolar Floating Ball Device

K022532510(k) TraditionalCleared Feb 12, 2003196-day reviewClass II21 CFR 878.4400Recalls 2

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

Tissuelink Medical, Inc. · GEI Electrosurgical, Cutting & Coagulation & Accessories

Cleared on Feb 12, 2003 as substantially equivalent to K020574 (Tissuelink Medical, Inc., 2002) after a 196-day review. Its family tree reaches back 1 generation to 2002. 25 later devices descend from it. It has been recalled 2 times.

Decided
Feb 12, 2003
Review
196 days
Class
Class II
Product code
GEI
Recalls
2
Predicates
1

Its longest line of descent runs back 1 generation to K020574 (2002). 25 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 2005: 1 descendant cleared2011: 3 descendants cleared2008: 1 descendant cleared2014: 1 descendant cleared2013: 3 descendants cleared2021: 2 descendants cleared2010: 1 descendant cleared2007: 1 descendant cleared2019: 2 descendants cleared2012: 2 descendants cleared2022: 2 descendants cleared2017: 2 descendants cleared2023: 3 descendants cleared2020: 1 descendant clearedK020574 · Tissuelink Bipolar Floating Ball Device · Tissuelink Medical, Inc. · 2002 · recalled200020052010201520202025
Descendants, by generation 1 generation forward: 1 descendant2 generations forward: 10 descendants3 generations forward: 10 descendants4 generations forward: 3 descendants5 generations forward: 1 descendant K020574 · Tissuelink Bipolar Floating Ball Device · Tissuelink Medical, Inc. · 2002 · recalled0+5
  1. Root · 1 generation backK020574 Tissuelink Bipolar Floating Ball DeviceTissuelink Medical, Inc. · 2002 · Recalled
  2. This deviceK022532 Tissuelink Bipolar Floating Ball DeviceTissuelink Medical, Inc. · 2003
  3. Descendant · cites it directly · 24 of its ownK052859 Aquamantys Pump Generator SystemTissuelink Medical, Inc. · 2005 · Recalled
  4. Descendant · 2 generations on · 7 of its ownK063639 Aquamantys SS4.0 Bipolar Sealer, Model 23-121-1Tissuelink Medical, Inc. · 2007
  5. Descendant · 2 generations on · 5 of its ownK111732 Aquamantys SBS 5.0 Sheated Biopolar SealerSalient Surgical Technologies, Inc. · 2011
  6. Descendant · 2 generations on · 4 of its ownK132974 Aquamantys 2.3 Bipolar Sealer, Evs 4.0 Epidural Vein Sealer, Mini…Medtronic Advanced Energy, LLC · 2013
  7. Descendant · 2 generations on · 4 of its ownK130110 Meddusa Bipolar SystemElliquence, LLC · 2013

Showing 5 of 25 descendants. See all descendants

Descendants cleared per year

2005: 12007: 12008: 12010: 12011: 32012: 22013: 32014: 12017: 22019: 22020: 12021: 22022: 22023: 3
2005high 3 (2011) · low 0 (2006)2026

Most influential descendants

Showing 5 of 25 · See all
  • K052859Aquamantys Pump Generator SystemTissuelink Medical, Inc. · 2005 · cites it directly24descendants
  • K063639Aquamantys SS4.0 Bipolar Sealer, Model 23-121-1Tissuelink Medical, Inc. · 2007 · 2 generations on7descendants
  • K111732Aquamantys SBS 5.0 Sheated Biopolar SealerSalient Surgical Technologies, Inc. · 2011 · 2 generations on5descendants
  • K132974Aquamantys 2.3 Bipolar Sealer, Evs 4.0 Epidural Vein Sealer, Mini Evs 3.4 Epidural Vein…Medtronic Advanced Energy, LLC · 2013 · 2 generations on4descendants
  • K130110Meddusa Bipolar SystemElliquence, LLC · 2013 · 2 generations on4descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K020574Tissuelink Bipolar Floating Ball DeviceTissuelink Medical, Inc.20022
0 (this device)K022532Tissuelink Bipolar Floating Ball DeviceTissuelink Medical, Inc.2003—
+1K052859Aquamantys Pump Generator SystemTissuelink Medical, Inc.20051
+2K063639Aquamantys SS4.0 Bipolar Sealer, Model 23-121-1Tissuelink Medical, Inc.2007—
+2K111732Aquamantys SBS 5.0 Sheated Biopolar SealerSalient Surgical Technologies, Inc.2011—
+2K132974Aquamantys 2.3 Bipolar Sealer, Evs 4.0 Epidural Vein Sealer, Mini Evs 3.4…Medtronic Advanced Energy, LLC2013—
+2K130110Meddusa Bipolar SystemElliquence, LLC2013—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200510
200710
200810
201010
201130
201220
201330
201410
201720
201920
202010
202120
202220
202330
FIG. 1 — Lineage of K022532, 2002–2023Source: FDA 510(k) summaries, read by 510(k) Report · 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), 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? (1)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

TypeNumberDeviceApplicantDecidedRecalls
*K020574Tissuelink Bipolar Floating Ball Device
Summary page 1
…e Devices: Claim of Substantial Equivalence of the TissueLink Bipolar Floating Ball device :is made 'to: Identical device, TissueLink Bipolar Floating Ball, K#020574 TissueLink Medical, Inc. 14…
Tissuelink Medical, Inc.20022

Also cleared against K020574: 1 other device →

What descends from it? (25)

See all 25

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

NumberDeviceApplicantDecidedDescendants
K052859Aquamantys Pump Generator SystemTissuelink Medical, Inc.200524

Has anything in its family been recalled? (0 Class I)

Recalls of this device

DateClassRecallRoot causeReason
Jul 22, 2004Not classifiedZ-1416-04OtherAdapter when connected to a generator may short circuit resulting in lack of power and/or thermal warming of the ADP housing.
Jul 22, 2004Not classifiedZ-1415-04OtherAdapter when connected to a generator may short circuit resulting in lack of power and/or thermal warming of the ADP housing.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Its one ancestor has a recall.
  • Of its descendants, K052859 (Tissuelink Medical, Inc., 2005) has gone furthest, with 24 descendants of its own.
  • 1 other device also cites its predicate K020574.

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.

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 TissueLink Bipolar Floating Ball device is a sterile, single use electrosurgery device

intended to be used in conjunction with an electrosurgical generator for delivery of

radiofrequency current and saline for hemostatic sealing and coagulation of soft tissue and bone

at the operative site. It is intended for, but not limited to, endoscopic and open abdominal,

orthopaedic, spine and thoracic surgery. The device is not intended for contraceptive tubal

coagulation (permanent female sterilization).

Indications for use as stated in the FDA summary.

Also cleared against K020574

1 other device cites the same predicate.

  • K052859Aquamantys Pump Generator SystemTissuelink Medical, Inc. · 20051 recall

More from Tissuelink Medical, Inc.

12 FDA decisions under this applicant name. See the company

  • K073495Tissuelink Aquamantys Malleable Bipolar Sealer with LightTissuelink Medical, Inc. · 2008
  • K063639Aquamantys SS4.0 Bipolar Sealer, Model 23-121-1Tissuelink Medical, Inc. · 2007
  • K052859Aquamantys Pump Generator SystemTissuelink Medical, Inc. · 20051 recall
  • K032132Tissuelink Floating Ball Model 23-201-1Tissuelink Medical, Inc. · 2003
  • K030380Tissuelink Sealing Forceps, Model 1 21-202-1Tissuelink Medical, Inc. · 2003

Recent decisions in GEI

The GEI category page

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  • K254185Potenza PrimeJeisys Medical Incorporated · 2026

https://510kreport.com/device/K022532 · printed Nov 4, 2026

Cite this page

510(k) Report. “K022532: Tissuelink Bipolar Floating Ball Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K022532

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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