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510(k) K933261

GRASPING FORCEPS by Surgitek — Product Code FGO

K933261 is an FDA 510(k) premarket notification submitted by Surgitek for the device "GRASPING FORCEPS". The FDA issued a decision of Substantially Equivalent on January 11, 1994. The device falls under product code FGO (Dislodger, Stone, Flexible), a Class II device regulated under 21 CFR 876.4680. Surgitek has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 11, 1994
Date Received
July 6, 1993
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 Surgitek

  • K946296 — QUADRA-COIL URETERAL STENT (March 6, 1995)
  • K944391 — OM-4 (TENATIVE) URODYNAMIC MEASRUEMENT SYSTEM (February 7, 1995)
  • K943491 — RIGHT ANGLE UROLOGIC LASER FIBER (August 5, 1994)
  • K941952 — SURGITEK INFUSER (May 24, 1994)
  • K933260 — HELICAL STONE/FLATWIRE STONE BASKETS (January 11, 1994)
  • K930733 — URETERAL STENT (July 23, 1993)
  • K930483 — URETERAL CATHETER (July 16, 1993)
  • K926344 — HYDROPHILIC COATED GUIDEWIRE (March 5, 1993)
  • K920451 — ENDOTEK ULTRA SYSTEM (September 17, 1992)
  • K922542 — GRASPING FORCEPS (August 19, 1992)

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)
  • K934598 — GRASPING FORCEPS OR RETRIEVAL FORCEPS (January 7, 1994)
  • K921295 — INTRAVENOUS CATHETERS MODIFICATIONS (May 17, 1993)
  • K922542 — GRASPING FORCEPS (August 19, 1992)
  • K914110 — GRASPING FORCEPS (February 28, 1992)
  • K914111 — METAL URETERAL BASKET STONE DISLODGER, HELICAL (February 28, 1992)

FDA data resources