Atlas FDA

JOS

36 FDA 510(k) clearances · Product code

84 daysmedian time to decision
157 days90th percentile
36clearances measured

FDA profile

Official device name
Electrode, Electrosurgical
Device class
Class II (moderate risk)
Regulation
21 CFR 878.4400
Medical specialty
General, Plastic Surgery
Flags
Third-party review eligible
Adverse events (MAUDE)
2012: 7 · 2014: 7 · 2015: 13 · 2019: 17 · 2020: 12 · 2026: 12
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free

RecordFirmDate
Resection Electrodes (K161600)Olympus Winter & Ibe GmbH2016-09-06
LIGHTWAVE INTEGRATED ELECTRODE ABLATOR AND LIGHT WAVE INTEGRATED ELECTRODE SUCTION ABLATOR (K050923)Conmed Linvatec2005-05-18
REPROCESSED ELECTROSURGICAL ELECTRODE (K012684)Sterilmed, Inc.2002-01-18
MEDLINE GROUNDING PAD (K011515)Medline Industries, Inc.2001-07-13
ENDOSCOPIC MONOPOLAREECTRODE, MODEL EME- 1000 TO 1999 (K003403)Highland / Marietta, Inc.2001-05-07
STANDARD & EXTENDED BLADE, STANDARD & EXTENDED NEEDLE, STANDARD & EXTENDED BALL, MODIFIED STANDARD & EXTENDED BLADE, MOD (K000333)Triad Surgical Technologies, Inc.2000-05-03
ULTRABLATOR ELECTRODE (K993885)Linvatec Corp.2000-02-10
CAPSULAR SHRINKAGE ELECTRODE (K991830)Linvatec Corp.1999-08-20
STANDARD AND EXTENDED BLADE, NEEDLE AND BALL; MODIFIED STANDARD AND EXTENDED BLADE & NEEDLE; STANDARD 45 DEGREE BLADE (K974735)Aaron Medical Industries1998-06-24
VALLEY FORGE BIPOLAR BALL TIP ELECTRODE (K973554)Valley Forge Scientific Corp.1997-12-19
STANDARD & EXTENDED BLADE/NEEDLE/BALL;MODIFIED STANDARD & EXTENDED BLADE/NEEDLE (K971187)Aaron Medical Industries1997-05-05
MICRO DIAMOND-POINT DISSECTION NEEDLES (K962544)Dsp Worldwide1996-09-20
MODIFIED LEVEEN NEEDLE ELECTRODE (K962313)Radiotherapeutics Corp.1996-09-11
SENTRY DISPOSABLE DISPERSIVE ELECTRODE (K955636)Sentry Medical Products, Inc.1996-03-27
MIST ELECTROSURGICAL PROBES, VARIOUS STYLES & SIZES, SURGICAL INSTRUMENTS USED DURING ENDOSCOPIC PROCEDURES (K952290)Mist, Inc.1995-06-23
MIST ELECTROSURGICAL PROBES, VARIOUS STYLES & SIZES (K952323)Mist, Inc.1995-06-23
DEVICE, ELECTROSURGICAL, CUTTING AND COAGULATION & ACCESSORIES (K950455)Aaron Medical Industries1995-05-16
ELECTRODES (K944992)Linvatec Corp.1995-04-27
MILES SODIUM METHOD (K923037)Heraeus Kulzer, Inc.1992-09-22
ELECTRODE EXTENDER (K905060)Megadyne Medical Products, Inc.1991-04-12
ELECTRODE, ELECTROSURGERY (K903302)Megadyne Medical Products, Inc.1990-10-02
ELECTROSURGICAL ELECTRODE (K895331)New England Surgical Instrument Corp.1989-09-15
MICRO CAUTERY NEEDLES (K891400)Zinnanti Surgical Instruments, Inc.1989-04-06
STRAIGHT PADDLE SURGICAL CAUTERY ELECTRODE BLADE (K890973)Instrument Makar, Inc.1989-03-22
HOOK TIP SURGICAL CAUTERY ELECTRODE BLADE (K890972)Instrument Makar, Inc.1989-03-22
INFANT ELECTROSURGICAL DISPERSIVE ELECTRODE (K882421)Dermacare Products, Inc.1988-06-30
COLORADO NEEDLE ELECTRODE (K881763)Colorado Biomedical, Inc.1988-06-20
YESNG PATIENT PLATE #80226 (K881144)Ferguson Medical1988-04-08
STRATUM ESU (K874719)Alternative Design Systems, Inc.1988-02-16
MONOPOLAR CAUTERY BLADE TIP #TM-1701 (K873653)Arthropedics, Inc.1987-12-15
MONOPOLAR CAUTERY CONICAL TIP #TM-1702 (K873654)Arthropedics, Inc.1987-12-15
MONOPOLAR CAUTERY RETROGADE TIP #TM-1703 (K873655)Arthropedics, Inc.1987-12-15
ELECTROSURGICAL CUTTING & COAGULATION (K810628)Intermedics, Inc.1981-04-03
BIPOLAR FORCEPS (K792365)Concept, Inc.1979-12-10
INFANT ELECTROSURGICAL GROUNDING PAD (K780405)New Dimensions IN Medicine, Inc.1978-04-05
ELECTROSURGICAL GROUNDING PAD (K772160)Ndm Corp.1977-11-28

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Every clearance here is in the API, with alerts when new ones post.