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510(k) K914015

CLEMENT-PILLING CHOLANGIOGRAPHY CATH GUIDE/CLAMP by Pilling Co. — Product Code GBZ

K914015 is an FDA 510(k) premarket notification submitted by Pilling Co. for the device "CLEMENT-PILLING CHOLANGIOGRAPHY CATH GUIDE/CLAMP". The FDA issued a decision of Substantially Equivalent on November 21, 1991. The device falls under product code GBZ (Catheter, Cholangiography), a Class I device regulated under 21 CFR 878.4200. Pilling Co. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 21, 1991
Date Received
September 9, 1991
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 Pilling Co.

  • K002582 — PILLING E-FRAZIER BIPOLAR SUCTION TUBE (November 3, 2000)
  • K934427 — PILLING LAPAROSCOPIC INSTRUMENTATION (January 10, 1994)
  • K925370 — TRIANGULAR JAW MICROLARYNGEAL FORCEPS (March 18, 1993)
  • K925198 — KAISER NO CANNULA THORACOSCOPY/LAPAROSCOPY INSTR (February 12, 1993)
  • K922971 — NO-SCALPEL VASCETOMY INSTRUMENTS (September 23, 1992)
  • K911099 — MEHIGAN-PILLING ANGIOSCOPIC VASCULAR INSTRUM. LINE (June 25, 1991)
  • K911100 — MEHIGAN-PILLING PHLEBETOME TM (June 21, 1991)
  • K904507 — PILLING BRUSH VALVULOTOME (March 1, 1991)
  • K884946 — JEHLE CORONARY PERFUSION CATHETERS (February 6, 1989)
  • K882930 — LASER LARYNGOSCOPE DEDO ARTICULA. & FEDER DEDO EX (August 16, 1988)

Other clearances for product code GBZ

  • K973621 — PRE-VIEW CHOLANGIOGRAPHY CLAMP (December 17, 1997)
  • 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)
  • K926143 — ANGIOLAPCATH CHOLANGIOGRAPHY KIT (July 7, 1993)
  • K924212 — STRYKER ENDOSCOPY CHOLANGIOGRAM 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)

FDA data resources