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510(k) K993885

ULTRABLATOR ELECTRODE by Linvatec Corp. — Product Code JOS

K993885 is an FDA 510(k) premarket notification submitted by Linvatec Corp. for the device "ULTRABLATOR ELECTRODE". The FDA issued a decision of Substantially Equivalent on Feb 10, 2000. The device falls under product code JOS (Electrode, Electrosurgical), a Class II device regulated under 21 CFR 878.4400. Linvatec Corp. has 92 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
Feb 10, 2000
Date Received
Nov 16, 1999
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Electrode, Electrosurgical
Device Class
Class II
Regulation Number
878.4400
Review Panel
SU
Submission Type
510(k)

Other clearances by Linvatec Corp.

  • K092998 — CONMED LINVATEC INTERCEPT IMPLANT (Dec 23, 2009)
  • K091549 — CONMED LINVATEC SOFT TISSUE TO BONE SYSTEM (Jun 23, 2009)
  • K090835 — CONMED LINVATEC BIO MINI-REVO SUTURE ANCHOR, MODEL C6170CR (Jun 22, 2009)
  • K090186 — CONMED LINVATEC PALADIN, PRELOADED WITH TWO #2 HI-FI SUTURES (Apr 10, 2009)
  • K083281 — EL LIGHTWAVE SUCTION ABLATOR, MODEL EL-2000-S, LIGHTWAVE SUCTION ABLATOR, MODEL… (Feb 25, 2009)
  • K060198 — MICROPOWER HAND PIECE : MEDIUM SPEED DRILL, SAGGITAL SAW, RECIPROCATING SAW, AND… (May 11, 2006)
  • K060270 — MICROPOWER HAND PIECE: ORAL MAX HIGH SPEED DRILL (Apr 10, 2006)
  • K060260 — MICROPOWER HAND PIECE HIGH SPEED DRILL (Apr 10, 2006)
  • K050519 — ADVANCED TURBO DRIVE SYSTEM (May 17, 2005)
  • K050497 — BIOSCREW XTRALOK, 8X35MM & 8X40MM VIOLET (Mar 25, 2005)

Other clearances for product code JOS

  • K161600 — Resection Electrodes (Sep 6, 2016)
  • K050923 — LIGHTWAVE INTEGRATED ELECTRODE ABLATOR AND LIGHT WAVE INTEGRATED ELECTRODE… (May 18, 2005)
  • K012684 — REPROCESSED ELECTROSURGICAL ELECTRODE (Jan 18, 2002)
  • K011515 — MEDLINE GROUNDING PAD (Jul 13, 2001)
  • K003403 — ENDOSCOPIC MONOPOLAREECTRODE, MODEL EME- 1000 TO 1999 (May 7, 2001)
  • K000333 — STANDARD & EXTENDED BLADE, STANDARD & EXTENDED NEEDLE, STANDARD & EXTENDED BALL… (May 3, 2000)
  • K991830 — CAPSULAR SHRINKAGE ELECTRODE (Aug 20, 1999)
  • K974735 — STANDARD AND EXTENDED BLADE, NEEDLE AND BALL; MODIFIED STANDARD AND EXTENDED… (Jun 24, 1998)
  • K973554 — VALLEY FORGE BIPOLAR BALL TIP ELECTRODE (Dec 19, 1997)
  • K971187 — STANDARD & EXTENDED BLADE/NEEDLE/BALL;MODIFIED STANDARD & EXTENDED BLADE/NEEDLE (May 5, 1997)

FDA data resources