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510(k) K900566

RICHARD-ALLAN VESSEL LOOPS by Richard-Allan Medical Ind., Inc. — Product Code KDC

K900566 is an FDA 510(k) premarket notification submitted by Richard-Allan Medical Ind., Inc. for the device "RICHARD-ALLAN VESSEL LOOPS". The FDA issued a decision of Substantially Equivalent on May 3, 1990. The device falls under product code KDC (Instrument, Surgical, Disposable), a Class I device regulated under 21 CFR 878.4800. Richard-Allan Medical Ind., Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 3, 1990
Date Received
February 7, 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 Richard-Allan Medical Ind., Inc.

  • K931879 — REFLEX HTR (March 24, 1994)
  • K924200 — REFLEX(R) ESC (February 22, 1994)
  • K926297 — REFLEX ESI (October 15, 1993)
  • K924761 — STERILE ENDOSCOPIC DISPOS TROCARS W/SAFE SHIELD (April 20, 1993)
  • K896262 — TITANIUM LIGATING CLIPS (January 2, 1990)
  • K890314 — PROTECTOR (SURGICAL INSTRUMENT) (February 27, 1989)
  • K873309 — REFLEX(TM) CA-T CLIP APPLIER (November 27, 1987)
  • K862404 — REFLEX(TM) CLIP APPLIER (July 23, 1986)
  • K862223 — MICRO THIN* PARAFFIN (June 17, 1986)
  • K861890 — 100%, 95%, 80% & 70% DEHYDRANT CUSTOM BLEND NO. 2 (June 3, 1986)

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)
  • K905240 — VESSELOOPS (February 6, 1991)
  • K903649 — BRADLEY TENACULUM HOLDER (November 2, 1990)

FDA data resources