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510(k) K891253

UROLOGICAL GRASPING FORCEPS by Northgate Research, Inc. — Product Code FGO

K891253 is an FDA 510(k) premarket notification submitted by Northgate Research, Inc. for the device "UROLOGICAL GRASPING FORCEPS". The FDA issued a decision of Substantially Equivalent on March 22, 1989. The device falls under product code FGO (Dislodger, Stone, Flexible), a Class II device regulated under 21 CFR 876.4680. Northgate Research, Inc. has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 22, 1989
Date Received
March 8, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Dislodger, Stone, Flexible
Device Class
Class II
Regulation Number
876.4680
Review Panel
GU
Submission Type

Other clearances by Northgate Research, Inc.

  • K903337 — 1.9 FRENCH LITHOTRIPTER ELECTRODE (November 16, 1990)
  • K894704 — 2.5 FRENCH LITHOTRIPTOR ELECTRODE (October 18, 1989)
  • K891252 — UROLOGICAL LOOP RETRIEVERS (March 22, 1989)
  • K891254 — UROLOGICAL STONE BASKET (March 22, 1989)
  • K864904 — 3F ELECTRODE (February 10, 1987)
  • K852874 — 5F ELECTRODE(LITHOTRIPTOR) (August 21, 1985)
  • K802322 — MODEL SD-1 DISINTEGRATOR (November 10, 1980)

Other clearances for product code FGO

  • K001563 — SCIPRO(TM) FLEXIBLE STONE DISLODGER AND RETRIEVAL SET (November 22, 2000)
  • K970121 — STONE DISLODGER, BASKET (April 2, 1997)
  • K963750 — RETRIEVAL SNARE (November 22, 1996)
  • K962676 — DISPOSABLE ENDOSCOPIC RETRIEVAL DEVICE (October 4, 1996)
  • K951309 — STONE DISLODGER, BASKET (May 17, 1995)
  • K933261 — GRASPING FORCEPS (January 11, 1994)
  • K934598 — GRASPING FORCEPS OR RETRIEVAL FORCEPS (January 7, 1994)
  • K921295 — INTRAVENOUS CATHETERS MODIFICATIONS (May 17, 1993)
  • K922542 — GRASPING FORCEPS (August 19, 1992)
  • K914111 — METAL URETERAL BASKET STONE DISLODGER, HELICAL (February 28, 1992)

FDA data resources