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510(k) K905240

VESSELOOPS by Sparta Surgical Corp. — Product Code KDC

K905240 is an FDA 510(k) premarket notification submitted by Sparta Surgical Corp. for the device "VESSELOOPS". The FDA issued a decision of Substantially Equivalent on February 6, 1991. The device falls under product code KDC (Instrument, Surgical, Disposable), a Class I device regulated under 21 CFR 878.4800. Sparta Surgical Corp. has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 6, 1991
Date Received
November 20, 1990
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 Sparta Surgical Corp.

  • K965187 — SPECTRUM II, SPECTRUM PLUS, AND SPECTRUM MAX-SD (August 1, 1997)
  • K945313 — SPARTA HYDROGEL WOUND DRESSING (January 12, 1995)
  • K922729 — SPARTA WET DRESSING, SODIUM CHLORIDE (November 23, 1992)
  • K905384 — DAVID SIMMONDS ANESTHESIA EXTENSION TUBES (March 22, 1991)
  • K896085 — SURGI-BRUSH (November 8, 1989)
  • K896084 — MICROSPEARS (November 2, 1989)

Other clearances for product code KDC

  • K943229 — DISPOSABLE SURGICAL SCISSORS AND FORCEPS (August 19, 1994)
  • K936226 — SURGIMED BREAST LOCALIZATION NEEDLE WIRE SET (March 7, 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)
  • K903649 — BRADLEY TENACULUM HOLDER (November 2, 1990)
  • K900566 — RICHARD-ALLAN VESSEL LOOPS (May 3, 1990)

FDA data resources