510(k) Report

510(k) · Cleared

Cleared

Symbiosis Bipolar Scissors

K950286510(k) TraditionalCleared Feb 3, 199510-day reviewClass II21 CFR 876.1500

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

Symbiosis Corp. · GCJ Laparoscope, General & Plastic Surgery

Cleared on Feb 3, 1995 after a 10-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 101 later devices descend from it.

Decided
Feb 3, 1995
Review
10 days
Class
Class II
Product code
GCJ
Recalls
None
Predicates
0

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

Descendants, by year cleared 2001: 1 descendant cleared1999: 1 descendant cleared2004: 3 descendants cleared2008: 11 descendants cleared2002: 1 descendant cleared2006: 10 descendants cleared2000: 1 descendant cleared2003: 2 descendants cleared2016: 2 descendants cleared2011: 4 descendants cleared2005: 2 descendants cleared2007: 4 descendants cleared2012: 9 descendants cleared2010: 3 descendants cleared2009: 3 descendants cleared2021: 2 descendants cleared2022: 3 descendants cleared2019: 8 descendants cleared2018: 5 descendants cleared2014: 5 descendants cleared2013: 3 descendants cleared2025: 2 descendants cleared2024: 6 descendants cleared2020: 2 descendants cleared2017: 1 descendant cleared2015: 1 descendant cleared2026: 4 descendants cleared2023: 2 descendants cleared1995200020052010201520202025
  1. This deviceK950286 Symbiosis Bipolar ScissorsSymbiosis Corp. · 1995
  2. Descendant · cites it directly · 92 of its ownK011722 Atricure Bipolar Coagulation SystemAtriCure, Inc. · 2001
  3. Descendant · 2 generations on · 90 of its ownK020919 Atricure Bipolar System, Models ASU1, ASU2, ASU3, LHP1, LHP2, RHP1AtriCure, Inc. · 2002
  4. Descendant · 3 generations on · 42 of its ownK040690 Surgifrost 10 CM Cryosurgical Device Plus Frostbyte Clamp and…Cryocath Technologies, Inc. · 2004
  5. Descendant · 3 generations on · 34 of its ownK031247 Cardioblate Bipolar Radiofrequency Surgical Ablation SystemMedtronic Vascular · 2003
  6. Descendant · 2 generations on · 23 of its ownK022894 Epicor Medical Ablation SystemEpicor Medical, Inc. · 2004

Showing 5 of 101 descendants. See all descendants

Descendants cleared per year

1999: 12000: 12001: 12002: 12003: 22004: 32005: 22006: 102007: 42008: 112009: 32010: 32011: 42012: 92013: 32014: 52015: 12016: 22017: 12018: 52019: 82020: 22021: 22022: 32023: 22024: 62025: 22026: 4
1999high 11 (2008) · low 1 (1999)2026

Most influential descendants

Showing 5 of 101 · See all
  • K011722Atricure Bipolar Coagulation SystemAtriCure, Inc. · 2001 · cites it directly92descendants
  • K020919Atricure Bipolar System, Models ASU1, ASU2, ASU3, LHP1, LHP2, RHP1AtriCure, Inc. · 2002 · 2 generations on90descendants
  • K040690Surgifrost 10 CM Cryosurgical Device Plus Frostbyte Clamp and Cryosurgical ConsoleCryocath Technologies, Inc. · 2004 · 3 generations on42descendants
  • K031247Cardioblate Bipolar Radiofrequency Surgical Ablation SystemMedtronic Vascular · 2003 · 3 generations on34descendants
  • K022894Epicor Medical Ablation SystemEpicor Medical, Inc. · 2004 · 2 generations on23descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K950286Symbiosis Bipolar ScissorsSymbiosis Corp.1995—
+1K011722Atricure Bipolar Coagulation SystemAtriCure, Inc.2001—
+2K020919Atricure Bipolar System, Models ASU1, ASU2, ASU3, LHP1, LHP2, RHP1AtriCure, Inc.2002—
+3K040690Surgifrost 10 CM Cryosurgical Device Plus Frostbyte Clamp and Cryosurgical…Cryocath Technologies, Inc.2004—
+3K031247Cardioblate Bipolar Radiofrequency Surgical Ablation SystemMedtronic Vascular2003—
+2K022894Epicor Medical Ablation SystemEpicor Medical, Inc.2004—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199910
200010
200110
200210
200320
200430
200520
2006100
200740
2008110
200930
201030
201140
201290
201330
201450
201510
201620
201710
201850
201980
202020
202120
202230
202320
202460
202520
202640
FIG. 1 — Lineage of K950286, 1995–2026Source: 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), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in GCJ? 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 GCJ device

  1. #1 K214046 780 nm 1688 4K Camera System, 780 nm L11 LED…score 21.4 · 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?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (101)

See all 101

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

NumberDeviceApplicantDecidedDescendants
K011722Atricure Bipolar Coagulation SystemAtriCure, Inc.200192
K992996Enable Endoscopic Bipolar ScissorsEnable Medical Corp.19997

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, K011722 (AtriCure, Inc., 2001) has gone furthest, with 92 descendants of its own.

How does its category compare?

All GCJ devices

GCJ Laparoscope, General & Plastic Surgery: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · GCJ

21in 2025

2007: 182008: 192009: 212010: 242011: 152012: 172013: 152014: 192015: 262016: 272017: 202018: 212019: 152020: 282021: 182022: 202023: 312024: 292025: 212026 (partial year): 26
2007high 31 (2023) · low 15 (2011)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · GCJ

108in 2025

2007: 42 days median2008: 73 days median2009: 85 days median2010: 122 days median2011: 113 days median2012: 88 days median2013: 93 days median2014: 90 days median2015: 76 days median2016: 99 days median2017: 77 days median2018: 88 days median2019: 60 days median2020: 61 days median2021: 116 days median2022: 103 days median2023: 109 days median2024: 90 days median2025: 108 days median2026 (partial year): 122 days median
2007high 122 (2010) · low 42 (2007)2026

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

Recalls per year · GCJ

5in 2025

2007: 122008: 162009: 62010: 302011: 92012: 12013: 7, 1 Class I2014: 22016: 52017: 12018: 12022: 12023: 12025: 52026 (partial year): 1
2007high 30 (2010) · low 0 (2015)2026

Class I (1 since 2007) Class II/III not classified

Adverse event reports per year · GCJ

5,860in 2025

2007: 1,6392008: 1,3192009: 1,9952010: 2,6572011: 2,1332012: 1,5262013: 1,5652014: 1,7142015: 1,7102016: 2,0802017: 3,4682018: 2,5622019: 2,5782020: 2,6182021: 3,4312022: 3,9452023: 6,0022024: 6,0472025: 5,860
2007high 6,047 (2024) · low 1,319 (2008)2025

MAUDE reports naming product code GCJ, 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
20071842121,639
20081973161,319
2009218561,995
201024122302,657
20111511392,133
2012178811,526
201315937 (1)1,565
2014199021,714
2015267601,710
2016279952,080
2017207713,468
2018218812,562
2019156002,578
2020286102,618
20211811603,431
20222010313,945
20233110916,002
2024299006,047
20252110855,860
2026261221—

More from Symbiosis Corp.

34 FDA decisions under this applicant name. See the company

  • K955119Symbiosis Monopolar Electrosurgical Roller ElectrodesSymbiosis Corp. · 1996
  • K953453Symbiosis Monopolar Electrosurgical Roller ElectrodesSymbiosis Corp. · 1996
  • K953242Symbiosis Monoplar Electrosurgical ElectrodesSymbiosis Corp. · 1995
  • K952432Symbiosis Bipolar ForcepsSymbiosis Corp. · 1995
  • K951387Symbiosis Bipolar ScissorsSymbiosis Corp. · 1995

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https://510kreport.com/device/K950286 · printed Nov 4, 2026

Cite this page

510(k) Report. “K950286: Symbiosis Bipolar Scissors.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K950286

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Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026