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510(k) K973621

PRE-VIEW CHOLANGIOGRAPHY CLAMP by Nashville Surgical Instruments — Product Code GBZ

K973621 is an FDA 510(k) premarket notification submitted by Nashville Surgical Instruments for the device "PRE-VIEW CHOLANGIOGRAPHY CLAMP". The FDA issued a decision of Substantially Equivalent on December 17, 1997. The device falls under product code GBZ (Catheter, Cholangiography), a Class I device regulated under 21 CFR 878.4200. Nashville Surgical Instruments has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 17, 1997
Date Received
September 23, 1997
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Cholangiography
Device Class
Class I
Regulation Number
878.4200
Review Panel
SU
Submission Type

Other clearances by Nashville Surgical Instruments

  • K081366 — KUMAR T-ANCHORS HERNIA SET (July 15, 2008)

Other clearances for product code GBZ

  • K944790 — FLEXIBLE LAPAROSCOPIC CHOLANGIOGRAPHY CATHETER (November 29, 1994)
  • K942450 — ENDOPATH (August 5, 1994)
  • K932228 — MICROVASIVE INSURG CHLOANGIOGRAPHIC CATHETER (August 10, 1993)
  • K926217 — TERUMO ANGIOGRAPHIC CATHETER FOR LAPOROSCOPIC USE (July 13, 1993)
  • K924212 — STRYKER ENDOSCOPY CHOLANGIOGRAM KIT (July 7, 1993)
  • K926143 — ANGIOLAPCATH CHOLANGIOGRAPHY KIT (July 7, 1993)
  • K925742 — CLARUS CHOLANGIOGRAM CATHETER KIT (June 1, 1993)
  • K924981 — OPERATIVE CHOLANGIOGRAM CATHETER (April 6, 1993)
  • K924480 — CHOLANGIOGRAPHY CLAMP (March 3, 1993)
  • K924128 — CHOLANGIOGRAPHY CATHETER (February 10, 1993)

FDA data resources