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510(k) K932700

CUTO(TM) TISSUE MORCELLATION SYSTEM by Linvatec Corp. — Product Code GEY

K932700 is an FDA 510(k) premarket notification submitted by Linvatec Corp. for the device "CUTO(TM) TISSUE MORCELLATION SYSTEM". The FDA issued a decision of Substantially Equivalent on October 15, 1993. The device falls under product code GEY (Motor, Surgical Instrument, Ac-Powered), a Class I device regulated under 21 CFR 878.4820. Linvatec Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 15, 1993
Date Received
June 3, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Motor, Surgical Instrument, Ac-Powered
Device Class
Class I
Regulation Number
878.4820
Review Panel
SU
Submission Type

Other clearances by Linvatec Corp.

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

Other clearances for product code GEY

  • K050519 — ADVANCED TURBO DRIVE SYSTEM (May 17, 2005)
  • K020621 — ARTHROCARE CONTROLLER; ARTHROCARE CABLE; FOOT CONTROL; POWER CORD; WANDS (March 28, 2002)
  • K012738 — SYMPHONY GRAFT DELIVERY SYSTEM (GDS) (November 14, 2001)
  • K972308 — MEDNEXT 1000 DRILL (August 20, 1997)
  • K971941 — AQUA SPRAY (August 14, 1997)
  • K971782 — BONE AND MARROW COLLECTION SYSTEM KIT (July 29, 1997)
  • K971268 — BONE & MARROW CLLECTION SYSTEM (July 3, 1997)
  • K964252 — ORTHOCHUCK (May 27, 1997)
  • K970530 — ANSPACH LUBRICATING SYSTEM II (May 5, 1997)
  • K964073 — BME BONE DRILL BITS (November 14, 1996)

FDA data resources