510(k) Report

510(k) · Cleared

Cleared

Tissuelink Floating Ball Model 23-201-1

K032132510(k) SpecialCleared Aug 20, 200340-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

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

Cleared on Aug 20, 2003 after a 40-day review. The FDA summary names its predicate without a number. 44 later devices descend from it.

Decided
Aug 20, 2003
Review
40 days
Class
Class II
Product code
GEI
Recalls
None
Predicates
0

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

Descendants, by year cleared 2005: 2 descendants cleared2008: 2 descendants cleared2006: 1 descendant cleared2010: 2 descendants cleared2011: 3 descendants cleared2014: 2 descendants cleared2013: 4 descendants cleared2021: 2 descendants cleared2007: 2 descendants cleared2019: 6 descendants cleared2012: 6 descendants cleared2022: 3 descendants cleared2017: 3 descendants cleared2023: 3 descendants cleared2009: 1 descendant cleared2018: 1 descendant cleared2020: 1 descendant cleared200020052010201520202025
  1. This deviceK032132 Tissuelink Floating Ball Model 23-201-1Tissuelink Medical, Inc. · 2003
  2. Descendant · cites it directly · 24 of its ownK052859 Aquamantys Pump Generator SystemTissuelink Medical, Inc. · 2005 · Recalled
  3. Descendant · cites it directly · 18 of its ownK050459 Atricure Isolator Transpolar PenAtriCure, Inc. · 2005 · Recalled
  4. Descendant · 2 generations on · 13 of its ownK073605 Atricure Coolrail Linear PenAtriCure, Inc. · 2008
  5. Descendant · 2 generations on · 13 of its ownK061593 Atricure Isolator Transpolar Pen System, Models ASU2, MAX1, MAX2 and…AtriCure, Inc. · 2006 · Recalled
  6. Descendant · 2 generations on · 9 of its ownK100501 Multifunctional Linear PenAtriCure, Inc. · 2010

Showing 5 of 44 descendants. See all descendants

Descendants cleared per year

2005: 22006: 12007: 22008: 22009: 12010: 22011: 32012: 62013: 42014: 22017: 32018: 12019: 62020: 12021: 22022: 32023: 3
2005high 6 (2012) · low 0 (2015)2026

Most influential descendants

Showing 5 of 44 · See all
  • K052859Aquamantys Pump Generator SystemTissuelink Medical, Inc. · 2005 · cites it directly24descendants
  • K050459Atricure Isolator Transpolar PenAtriCure, Inc. · 2005 · cites it directly18descendants
  • K073605Atricure Coolrail Linear PenAtriCure, Inc. · 2008 · 2 generations on13descendants
  • K061593Atricure Isolator Transpolar Pen System, Models ASU2, MAX1, MAX2 and ASB1AtriCure, Inc. · 2006 · 2 generations on13descendants
  • K100501Multifunctional Linear PenAtriCure, Inc. · 2010 · 2 generations on9descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K032132Tissuelink Floating Ball Model 23-201-1Tissuelink Medical, Inc.2003—
+1K052859Aquamantys Pump Generator SystemTissuelink Medical, Inc.20051
+1K050459Atricure Isolator Transpolar PenAtriCure, Inc.20051
+2K073605Atricure Coolrail Linear PenAtriCure, Inc.2008—
+2K061593Atricure Isolator Transpolar Pen System, Models ASU2, MAX1, MAX2 and ASB1AtriCure, Inc.20061
+2K100501Multifunctional Linear PenAtriCure, Inc.2010—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200520
200610
200720
200820
200910
201020
201130
201260
201340
201420
201730
201810
201960
202010
202120
202230
202330
FIG. 1 — Lineage of K032132, 2003–2023Source: 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
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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
*—TissueLink Bipolar Floating Ball
Named without a submission number
—

What descends from it? (44)

See all 44

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K052859Aquamantys Pump Generator SystemTissuelink Medical, Inc.200524
K050459Atricure Isolator Transpolar PenAtriCure, Inc.200518

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, K052859 (Tissuelink Medical, Inc., 2005) has gone furthest, with 24 descendants 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.

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 BPS bipolar sealer 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.

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
  • K030380Tissuelink Sealing Forceps, Model 1 21-202-1Tissuelink Medical, Inc. · 2003
  • K022532Tissuelink Bipolar Floating Ball DeviceTissuelink Medical, Inc. · 20032 recalls

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The GEI category page

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https://510kreport.com/device/K032132 · printed Nov 6, 2026

Cite this page

510(k) Report. “K032132: Tissuelink Floating Ball Model 23-201-1.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K032132

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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