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510(k) K936226

SURGIMED BREAST LOCALIZATION NEEDLE WIRE SET by Meadox Medicals, Div. Boston Scientific Corp. — Product Code KDC

K936226 is an FDA 510(k) premarket notification submitted by Meadox Medicals, Div. Boston Scientific Corp. for the device "SURGIMED BREAST LOCALIZATION NEEDLE WIRE SET". The FDA issued a decision of Substantially Equivalent on March 7, 1994. The device falls under product code KDC (Instrument, Surgical, Disposable), a Class I device regulated under 21 CFR 878.4800. Meadox Medicals, Div. Boston Scientific Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 7, 1994
Date Received
December 29, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Instrument, Surgical, Disposable
Device Class
Class I
Regulation Number
878.4800
Review Panel
SU
Submission Type

Other clearances by Meadox Medicals, Div. Boston Scientific Corp.

  • K953647 — MS CLASSIQUE BALLOON CATHETER W/HYDROPASS COATING (May 16, 1997)
  • K960766 — MEADOX MEDICALS, INC. EXPANDED PTFE VASCULAR GRAFT (March 19, 1997)
  • K962433 — MEADOX EXXCEL EPTFE VASCULAR GRAFT (March 17, 1997)
  • K961847 — HEMASHIELD VANTAGE (VASCULAR GRAFT (January 22, 1997)
  • K962342 — HEMASHIELD FINESSE ULTRA-THIN, KNITTED CARDIOVASCULAR PATCH (September 10, 1996)
  • K955460 — MEADOX MEDICALS, INC., EXPANDED & EXTERNALLY SUPPORTED EXPANDED PTFE VASCULAR GR (May 30, 1996)
  • K952884 — NOPROFILE OLBERT CATHETER SYSTEM BALLOON DILATATION CATHETER (February 21, 1996)
  • K955349 — HEMASHIELD KNITTED DOUBLE VELOUR CARDIOVASCULAR FABRIC (February 14, 1996)
  • K953298 — MS CLASSIQUE BALLOON DIATATION CATHETER (February 8, 1996)
  • K954848 — HEMASHIELD MICROVEL VELOUR KNITTED VASCULAR GRAFT (February 1, 1996)

Other clearances for product code KDC

  • K943229 — DISPOSABLE SURGICAL SCISSORS AND FORCEPS (August 19, 1994)
  • K920153 — THERMUFF BAG (July 1, 1992)
  • K920263 — MANUAL SURGICAL INSTRUMENTS (May 6, 1992)
  • K915064 — DISPOSABLE CAUTERY ABRASIVE PAD (March 11, 1992)
  • K914960 — INSTRUMENT ORGANIZER (February 28, 1992)
  • K912834 — SHUR-GRIP (July 26, 1991)
  • K910079 — DISPOSABLE INTRODUCER SHEATH (February 27, 1991)
  • K905240 — VESSELOOPS (February 6, 1991)
  • K903649 — BRADLEY TENACULUM HOLDER (November 2, 1990)
  • K900566 — RICHARD-ALLAN VESSEL LOOPS (May 3, 1990)

FDA data resources