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510(k) K914913

GRICE FOOT PEDAL CONTROL/REDDICK IRRI/ASPIR SYST by Ideal Medical, Inc. — Product Code GDJ

K914913 is an FDA 510(k) premarket notification submitted by Ideal Medical, Inc. for the device "GRICE FOOT PEDAL CONTROL/REDDICK IRRI/ASPIR SYST". The FDA issued a decision of Substantially Equivalent on December 31, 1991. The device falls under product code GDJ (Clamp, Surgical, General & Plastic Surgery), a Class I device regulated under 21 CFR 878.4800. Ideal Medical, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 31, 1991
Date Received
November 1, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Clamp, Surgical, General & Plastic Surgery
Device Class
Class I
Regulation Number
878.4800
Review Panel
SU
Submission Type

Other clearances by Ideal Medical, Inc.

  • K944067 — PEANUT WAND, MODIFICATION (December 8, 1994)
  • K931115 — HATCHER STONE-EMBOLIS EXTRACTOR (August 20, 1993)
  • K926335 — IDEAS PEANUT WAND (June 24, 1993)
  • K922161 — GRICE SOFT TISSUE BIOPSY KIT (October 13, 1992)
  • K921922 — GRICE LAPAROSCOPIC SUTURING NEEDLE (July 8, 1992)
  • K915175 — REDDICK RETRACTOR (April 29, 1992)
  • K914880 — DUAL BALLOON EMBOLECTOMY CATHETER (March 16, 1992)
  • K913602 — IDEAS' PORT (January 2, 1992)
  • K912540 — CONTOUR-PORT (August 23, 1991)
  • K911601 — REDDICK TROCAR AND CANNULA (May 21, 1991)

Other clearances for product code GDJ

  • K153358 — Standard Clamp (May 2, 2016)
  • K930315 — THORACIC CLAMPS: SAROT, KANTOWITZ AND LAWRENCE (February 4, 1994)
  • K924223 — MAR-MED LIVER STRAP (March 18, 1993)
  • K922659 — GENERAL SURGERY CLAMP AND NEEDLE HOLDER (July 21, 1992)
  • K900956 — GS-7100 CHOLANGIOGRAM CLAMP, 5MM (April 18, 1990)
  • K901107 — MODIFIED AUTO SUTURE PURSTRING DISP. AUTOMATIC (April 9, 1990)
  • K895726 — VESSEL OCCLUDER (October 24, 1989)
  • K895591 — SILICONE INSTRUMENT SHODS (October 20, 1989)
  • K882169 — SURGICAL DUCT CLAMP (VINE) (June 17, 1988)
  • K881741 — STUART LEE CLIP (June 3, 1988)

FDA data resources