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510(k) K962789

SURGICAL KIT-ACUFEX MOSAICPLASTY SYSTEM by Smith & Nephew Endoscopy, Inc. — Product Code GEY

K962789 is an FDA 510(k) premarket notification submitted by Smith & Nephew Endoscopy, Inc. for the device "SURGICAL KIT-ACUFEX MOSAICPLASTY SYSTEM". The FDA issued a decision of Substantially Equivalent on August 14, 1996. The device falls under product code GEY (Motor, Surgical Instrument, Ac-Powered), a Class I device regulated under 21 CFR 878.4820. Smith & Nephew Endoscopy, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 14, 1996
Date Received
July 17, 1996
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 Smith & Nephew Endoscopy, Inc.

  • K103309 — OSTEORAPTOR CURVED 2.3 SUTURE ANCHORS (February 3, 2011)
  • K102660 — BIORAPTOR CURVED 2.3 PK SUTURE ANCHORS (December 13, 2010)
  • K093428 — SMITH & NEPHEW KNOTLESS INSTABILITY ANCHOR (December 17, 2009)
  • K083226 — SMITH & NEPHEW PEEK INTERFERENCE SCREW (January 30, 2009)
  • K083635 — SMITH & NEPHEW BIOSURE PK INTERFERENCE SCREW (January 30, 2009)
  • K082095 — ULTRASLIDE ACROMIOCLAVICULAR AND SYNDESMOTIC REPAIR DEVICE (October 21, 2008)
  • K050580 — SMITH & NEPHEW INTELIJET FLUID MANAGEMENT SYSTEMS (April 20, 2005)
  • K992396 — BIORCI SCREW (January 12, 2000)
  • K991500 — SMITH & NEPHEW SUTURE LOK (July 14, 1999)
  • K972599 — ACUFEX SCREW CANNULA (September 19, 1997)

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