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510(k) K820867

PERCUTANEOUS NEPHROSTOMY SET by Van-Tec, Inc. — Product Code GBO

K820867 is an FDA 510(k) premarket notification submitted by Van-Tec, Inc. for the device "PERCUTANEOUS NEPHROSTOMY SET". The FDA issued a decision of Substantially Equivalent on April 13, 1982. The device falls under product code GBO (Catheter, Nephrostomy, General & Plastic Surgery), a Class I device regulated under 21 CFR 878.4200. Van-Tec, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 13, 1982
Date Received
March 29, 1982
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Nephrostomy, General & Plastic Surgery
Device Class
Class I
Regulation Number
878.4200
Review Panel
SU
Submission Type

Other clearances by Van-Tec, Inc.

  • K880096 — VAN-TEC ASPIRATION BIOPSY SYSTEM W/COLLECTION CUP (March 2, 1988)
  • K880098 — VAN-TEC AUTO BIOPSY NEEDLE (March 2, 1988)
  • K880099 — VAN-TEC BLADDER EVACUATOR (March 2, 1988)
  • K880095 — BERGER PROSTATE CULTURE CYTOLOGY BRUSH (March 2, 1988)
  • K880094 — VAN-TEC ENDOPYELOTOMY KNIFE (February 29, 1988)
  • K874112 — VAN-TEC DOUBLE OCCLUSION BALLOON CATHETER (February 11, 1988)
  • K871777 — VAN-TEC REUSABLE HELICAL STONE BASKET (June 17, 1987)
  • K871779 — HELICAL STONE BASKET (DISPOSABLE) (June 17, 1987)
  • K870679 — VAN-TEC MODULAR FLEXIBLE CYSTOURETHROSCOPE (March 30, 1987)
  • K870557 — VAN-TEC PUMPING SYSTEM (March 30, 1987)

Other clearances for product code GBO

  • K041995 — MODIFICATION TO: GP GENERAL PURPOSE DRAINAGE CATHETER, MINI-PIG DRAINAGE CATHETE (August 19, 2004)
  • K021632 — GP GENERAL PURPOSE DRAINAGE CATHETER; MINI-PIGTAIL DRAINAGE CATHETER WITH LOCKIN (June 13, 2002)
  • K912109 — URESIL GENERAL PURPOSE DRAINAGE CATHETER (August 12, 1991)
  • K854905 — PERCUTANEOUS NEPHROSTOMY SETS (LOOP TECHNIQUE) (January 24, 1986)
  • K854911 — PERCUTANEOUS NEPHROSTOMY SETS (SCHULLER) (January 24, 1986)
  • K854906 — PERCUTANEOUS NEPHROSTOMY SETS (OTTO) (January 24, 1986)
  • K854907 — PERCUTANEOUS NEPHROSTOMY SETS (GUNTHER) (January 24, 1986)
  • K854909 — PEDIATRIC PERCUTANEOUS NEPHROSTOMY SETS (January 24, 1986)
  • K781664 — SILASTIC NEPHROSTOMY SYSTEM (January 22, 1979)
  • K781526 — SILASTIC U-TUBE KIT (September 20, 1978)

FDA data resources