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510(k) K932534

ISI FENESTRATED DISSECTING AND GRASPING FORCEPS by Innovative Surgical, Inc. — Product Code GFI

K932534 is an FDA 510(k) premarket notification submitted by Innovative Surgical, Inc. for the device "ISI FENESTRATED DISSECTING AND GRASPING FORCEPS". The FDA issued a decision of Substantially Equivalent on August 19, 1993. The device falls under product code GFI (Osteotome, Manual), a Class I device regulated under 21 CFR 878.4800. Innovative Surgical, Inc. has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 19, 1993
Date Received
May 28, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Osteotome, Manual
Device Class
Class I
Regulation Number
878.4800
Review Panel
SU
Submission Type

Other clearances by Innovative Surgical, Inc.

  • K945394 — INNOVATIVE SURGICAL(R) MANGUM KNOT PUSHER (January 27, 1995)
  • K932695 — ISI(R) PORPOISE NOSE DISSECTING FORCEPS (March 3, 1994)
  • K932696 — ISI(R) CURVED, TAPERED DISSECTING FORCEPS (March 3, 1994)
  • K934075 — ISI METZENBAUM SCISSORS (December 1, 1993)
  • K932697 — ISI(R) HOOK SUTURE SCISSORS, MONOPOLAR (November 10, 1993)
  • K932698 — ISI(R) HOOK SUTURES SCISSORS (October 27, 1993)

Other clearances for product code GFI

  • K933181 — VALLEYLAB FORCE GSU HANDSET ADAPTER MODEL #E0500 (November 2, 1993)
  • K920001 — HEMOLAB SILIMAT REAGENT (September 25, 1992)
  • K891887 — OSTEOTOMES, VARIOUS TYPES (April 12, 1989)
  • K852541 — STORZ ION BOND OSTEOTOMES & RASPS, FAST CU BURS (July 11, 1985)
  • K842823 — CHERMEL OSTEOTOMES (August 2, 1984)

FDA data resources