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510(k) K962771

BURKE CONGENITAL THORACOSCOPY INSTRUMENTS by Pilling Weck, Inc. — Product Code DWS

K962771 is an FDA 510(k) premarket notification submitted by Pilling Weck, Inc. for the device "BURKE CONGENITAL THORACOSCOPY INSTRUMENTS". The FDA issued a decision of Substantially Equivalent on November 19, 1996. The device falls under product code DWS (Instruments, Surgical, Cardiovascular), a Class I device regulated under 21 CFR 870.4500. Pilling Weck, Inc. has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 19, 1996
Date Received
July 16, 1996
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Instruments, Surgical, Cardiovascular
Device Class
Class I
Regulation Number
870.4500
Review Panel
CV
Submission Type

Other clearances by Pilling Weck, Inc.

  • K990547 — PILLING WECK SURGICAL Y STENT FORCEPS (April 27, 1999)
  • K974250 — VERSASTAT MULTIPOLAR SCISSORS AND CABLES (February 11, 1998)
  • K945520 — HEMOCLIP ECOSYSTEM (January 27, 1995)
  • K944552 — PILLING WECK M-20 DISPOSABLE AUTOMATIC HEMOCLIP (November 7, 1994)
  • K943719 — VISISTAT STAPLER (August 24, 1994)

Other clearances for product code DWS

  • K022238 — MYOCARDIAL LEAD IMPLANT TOOL, MODEL 10626 (October 9, 2002)
  • K964445 — OCTOPUS TISSUE STABILIZER (28001/28002/28003/28004/28005/28006) (January 30, 1997)
  • K955689 — RNS STERILE, DISPOSABLE DIGITAL ANGIOGRAPHIC TRAY (May 15, 1996)
  • K960139 — G.E. STERILE ANGIOGRAPHIC TRAY (April 19, 1996)
  • K960144 — G.E. STERILE CT BIOPSY TRAY (April 15, 1996)
  • K960143 — G.E. STERILE DIGITAL ANGIOGRAPHIC TRAY (April 9, 1996)
  • K934727 — REPLACEMENT PARTS FOR CPI 6888 LEAD TUNNELER (January 10, 1994)
  • K900379 — HYCULT DIAMOND CORONARY BYPASS KNIFE (March 19, 1990)
  • K896307 — INSULATION PAD (January 19, 1990)
  • K894738 — MODEL 6888 LEAD TUNNELER (September 13, 1989)

FDA data resources