Atlas FDA

ELECTRODE, ELECTROSURGERY

FDA 510(k) clearance K903302 · decided 1990-10-02

Clearance details

K-number
K903302
Device name
ELECTRODE, ELECTROSURGERY
Applicant
Megadyne Medical Products, Inc.
Decision
Substantially Equivalent
Date received
1990-07-24
Decision date
1990-10-02
Days to decision
70 days
Clearance type
Traditional
Product code
JOS
Device class
2
Regulation number
878.4400
Medical specialty
General, Plastic Surgery
Advisory committee
General, Plastic Surgery
Location
Murray, UT, US
Third-party review
No
Expedited review
No

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Devices cleared under the same product code - the starting set for predicate research.

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

Recalls involving this device

No recalls on record reference this clearance.